A Phase 3 Open-Label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Treatment With a CDK4/6 Inhibitor

This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 + fulvestrant to capivasertib + fulvestrant for the treatment of patients with HR+/HER2- ABC with PIK3CA mutation following recurrence or progression on or after treatment with a CDK4/6 inhibitor.

Start Date31 Jul 2025

Sponsor / Collaborator

Relay Therapeutics, Inc.

NCT06979596

/ Not yet recruitingPhase 2

A Multicenter, Open-label, Phase 2 Basket Study of MK-5684 in Participants With Selected Solid Tumors (OMAHA-015)

Researchers want to learn if MK-5684 (the study medicine) can treat breast cancer, ovarian cancer, and endometrial cancer. MK-5684, the study medicine, is designed to treat cancer by blocking the body from making steroid hormones.
Researchers will compare MK-5684 to the standard treatments for each cancer type in this study.
The goal of this study is to learn if people who receive MK-5684 live longer without the cancer growing or spreading compared to people who receive a standard treatment.

Start Date17 Jul 2025

Sponsor / Collaborator

Merck Sharp & Dohme LLC

NCT06849947

/ Not yet recruitingPhase 2IIT

Randomized Phase II Trial of Fulvestrant With Ribociclib Versus Physician's Choice Treatments for the Patients Who Recurred After Completion of Adjuvant Cyclin-Dependent Kinase 4/6 Inhibitors in HR+, HER2- Metastatic Breast Cancer as First Line Treatment (CLEE011AKR06R)

▪ Fulvestrant With Ribociclib versus Physician's choice treatments for the patients who recurred after completion of Adjuvant Cyclin-Dependent Kinase 4/6 Inhibitors in HR+, HER2- Metastatic Breast Cancer as first line treatment

Start Date30 Jun 2025

Sponsor / Collaborator

Samsung Medical Center

100 Clinical Results associated with Fulvestrant

100 Translational Medicine associated with Fulvestrant

100 Patents (Medical) associated with Fulvestrant

6,638

Literatures (Medical) associated with Fulvestrant

01 Dec 2025·MOLECULAR BIOLOGY REPORTS

Clinical aspect of male breast cancer: a burgeoning and unaddressed issue

Review

Author: Mukherjee, Sukhes ; Ray, Suman Kumar

Rare among male cancers, male breast cancer (MBC) accounts for less than one percent of all male tumors. The prevalence of this illness and female breast cancer (FBC) have both been on the rise in recent years. While reports have implicated hormonal, environmental, and genetic variables in the development of MBC, nothing is known about its aetiology. Radiation exposure, hormonal imbalances caused by other medical conditions, and, most significantly, a positive family history of breast cancer-which indicates a hereditary predisposition-are major risk factors. While low-penetrance gene mutations (such as CHEK-2) are more prevalent, they do not enhance the risk of breast cancer development to the same extent as rare mutations in high-penetrance genes (such as BRCA1 and BRCA2). Speculated risk factors, including BRCA2 and lifestyle changes in the last few decades, are considered in light of the reasons for the rising occurrence. Topics covered include aromatase inhibitors, fulvestrant, and the prolactin and androgen receptor targeting pathways, as well as the therapeutic therapy of male breast cancer. Invasive ductal carcinomas, which account for about 90% of breast cancers in men, express many hormone receptors and show clear signs of treatment benefit. No single therapy method has been supported by published evidence from prospective randomized trials in MBC to yet. The treatment decision should be guided by the primary prognostic markers, which include tumor size and the number of axillary nodes involved. Detailed descriptions of the clinicopathologic characteristics of MBC are included in the present review. Our focus is on molecular profiling of MBC as a means to discover potential biomarkers and potential pharmacologic intervention targets. Endocrine treatment, which includes tamoxifen, aromatase inhibitors, and GnRH analogues, as well as cytotoxic chemotherapy, are characterized in light of the existing research. We also outline the possible function of targeted medications such as HER2-directed treatments, PARP inhibitors, and angiogenesis inhibitors.

01 Sep 2025·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY

Surface-enhanced Raman spectroscopy facilitates the detection of multiple metabolic modulators

Article

Author: Li, Yuanyuan ; Yang, Tao ; Ma, Yueyue ; Xia, Zhichao ; Zhou, Na ; Luo, Xiaojun ; Shen, Yushi

Metabolic regulators can improve the athletic ability of athletes by regulating body metabolism, but it is not conducive to fair competition, so it is listed as a prohibited substance. At the same time, the State General Administration of Sport ordered major event organizers to test food for food-borne stimulants. Surface-enhanced Raman scattering (SERS) spectroscopy has been widely used because of its excellent sensitivity and strong spectral characteristics. Based on the available information, SERS spectrum data of metabolic regulators in food-related fields were lacking. In this study, we used gold dodecahedron nanoparticles as SERS active substrate and successfully captured the characteristic peaks of 6 metabolic regulatory factors. A low cost and stable SERS detection technique for detecting trimetazidine in milk samples with good recovery rate was proposed. Therefore, this method can not only protect the food safety of large-scale sports events, but also have broad application prospects in the food field.

01 Aug 2025·BIOCHEMICAL PHARMACOLOGY

Methyl-oxazolomycin A: A novel oxazolomycin analog with potent selective estrogen receptor degrading activity in breast cancer cells

Article

Author: Oh, Dong-Chan ; Moon, Dong Hyun ; Kim, Seonghun ; Lee, Sang Kook ; Kim, Sanghee ; Park, Jiyoon

Breast cancer (BC), the most prevalent malignancy in women worldwide, is categorized according to the expression of estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) in tumor cells. Approximately 70% of all BCs are ER-positive and HER2-negative, and estrogen binding to the ER plays a vital role in BC development. We previously reported that methyl-oxazolomycin A, a natural compound isolated from Streptomyces sp. in soil, exhibited selective antiproliferative activity against ER-positive BC cells compared to triple-negative BC cells not expressing ER, PR, and HER2. The present study aimed to elucidate the molecular mechanisms underlying the antiproliferative activity of methyl-oxazolomycin A in two ER-positive BC lines, MCF-7 and T-47D. Methyl-oxazolomycin A effectively reduced the protein levels of ERα via proteasomal degradation while also reducing the protein levels of phosphorylated ERα. Notably, methyl-oxazolomycin A demonstrated potent antiproliferative activity in tamoxifen-resistant MCF-7 cells and downregulated the protein expression of phosphorylated ERα at Tyr537, which SERDs such as fulvestrant fail to target. The antiproliferative activity of methyl-oxazolomycin A was associated with the induction of the G₀/G₁ cell cycle arrest through the modulation of cell cycle checkpoint protein expression. Prolonged treatment with methyl-oxazolomycin A led to an increase in the production of reactive oxygen species and induced apoptosis. These findings, which detail the mechanisms underlying the antiproliferative activity of methyl-oxazolomycin A, support its potential as a novel agent targeting ER-positive BC cells.

574

News (Medical) associated with Fulvestrant

26 May 2025

·www.globenewswire.com

CHMP recommends EU approval of Roche’s Itovebi for PIK3CA-mutated, ER-positive, HER2-negative, advanced breast cancer

Positive recommendation based on phase III INAVO120 data showing ItovebiTM (inavolisib) in combination with palbociclib and fulvestrant more than doubled progression-free survival in the first-line setting1 The Itovebi-based regimen also demonstrated a statistically significant and clinically meaningful benefit in overall survival (OS) in the final OS analysis Final OS data will be presented in an oral session at the 2025 American Society of Clinical Oncology Annual Meeting 23 May 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Itovebi™ (inavolisib), in combination with palbociclib (Ibrance®) and fulvestrant, for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment. If approved, the Itovebi-based regimen has the potential to transform the standard of care in this first-line setting, where treatments are currently limited.1 A final decision regarding the approval is expected from the European Commission in the near future. “The positive CHMP recommendation for the Itovebi-based regimen represents a significant step towards providing people in the EU with PIK3CA-mutated, ER-positive advanced breast cancer with a targeted therapy in the first-line setting,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “This recommendation is further enforced by the recent final overall survival results from the INAVO120 study, showing the regimen can meaningfully extend survival.” The presence of a PIK3CA mutation, found in approximately 40% of hormone receptor (HR)-positive breast cancers, can make the disease more aggressive and worsen survival outcomes.2,3 This underscores the importance of testing for PIK3CA mutations prior to first-line treatment so that people with a poor prognosis can benefit from an effective, PI3K-targeted therapy as soon as possible. The CHMP’s positive opinion is based on the phase III INAVO120 results, published in the New England Journal of Medicine in October 2024, which showed a 57% reduction in the risk of disease worsening or death (progression-free survival [PFS]) with the Itovebi-based regimen compared with palbociclib and fulvestrant alone (15.0 months vs. 7.3 months; hazard ratio [HR]=0.43, 95% CI: 0.32-0.59, p1 The PFS benefit was consistent across all pre-specified subgroups, including people whose disease had spread to three or more locations, characterised as difficult-to-treat disease.1 The Itovebi-based regimen was well tolerated, with no new safety signals observed.1 Positive topline results from the final overall survival (OS) analysis, announced in January 2025, showed a statistically significant and clinically meaningful OS benefit with the Itovebi-based regimen. OS data were immature at the time of primary analysis, but a clear positive trend was observed (stratified HR=0.64, 95% CI: 0.43-0.97, p=0.0338 (boundary of 0.0098)).1 The full results from the OS analysis will be presented in an oral session at the 2025 American Society of Clinical Oncology Annual Meeting. The Itovebi-based regimen is approved for the treatment of adults with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer in the United States, Switzerland, Canada, Australia, United Arab Emirates and China, with data from INAVO120 under review with other global health authorities. Beyond INAVO120, Itovebi is currently being investigated in three company-sponsored phase III studies (INAVO121, INAVO122, INAVO123), all in PIK3CA-mutated, locally advanced or metastatic breast cancer in various combinations.4-7 We are exploring additional studies in breast cancer and other tumour types with the hope of providing the benefit of this targeted therapy to more people with PIK3CA mutations. Itovebi is an oral, targeted treatment that has been shown to provide well-tolerated and durable disease control in people with advanced PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer, who often have a poor prognosis and are in urgent need of new treatment options.1-3 Itovebi has been designed to help minimise the overall burden and toxicity of treatment and is differentiated from other PI3K inhibitors due to its high potency and specificity for the PI3K alpha isoform versus other isoforms, and unique mechanism of action that facilitates the degradation of mutated PI3K alpha.8,9 The INAVO120 study [NCT04191499] is a phase III, randomised, double-blind, placebo-controlled study evaluating the efficacy and safety of Itovebi™ (inavolisib) in combination with palbociclib and fulvestrant versus placebo plus palbociclib and fulvestrant in people with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.4 The study included 325 patients, who were randomly assigned to either the investigational or control treatment arm.4 The primary endpoint is progression-free survival, as assessed by investigators, defined as the time from randomisation in the clinical trial to the time when the disease progresses, or a patient dies from any cause.4 Secondary endpoints include overall survival, objective response rate, and clinical benefit rate.4 Beyond INAVO120, Itovebi is currently being investigated in three additional company-sponsored phase III clinical studies in PIK3CA-mutated, locally advanced or metastatic breast cancer in various combinations:5-7 in combination with fulvestrant versus alpelisib plus fulvestrant in HR-positive/HER2-negative breast cancer post cyclin-dependent kinase 4/6 (CDK4/6) inhibitor and endocrine combination therapy (INAVO121; NCT05646862). in combination with pertuzumab plus trastuzumab for subcutaneous injection (SC) versus pertuzumab plus trastuzumab for SC and optional physician's choice of endocrine therapy as a maintenance treatment in HER2-positive disease (INAVO122; NCT05894239). in combination with a CDK4/6 inhibitor and letrozole versus placebo plus a CDK4/6 inhibitor and letrozole in the first-line setting in PIK3CA-mutated HR-positive/HER2-negative, endocrine-sensitive breast cancer (INAVO123; NCT06790693). HR-positive breast cancer is the most prevalent type of all breast cancers, accounting for approximately 70% of cases.10,11 A defining feature of HR-positive breast cancer is that its tumour cells have receptors that attach to one or both hormones – oestrogen or progesterone – which can contribute to tumour growth. People diagnosed with HR-positive metastatic breast cancer often face the risk of disease progression and treatment side effects, creating a need for additional treatment options.11-13 The PI3K signalling pathway is commonly dysregulated in HR-positive breast cancer, often due to activating PIK3CA mutations, which have been identified as a potential mechanism of intrinsic resistance to standard of care endocrine therapy in combination with cyclin-dependent kinase 4/6 inhibitors.3 Roche has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have contributed to bringing breakthrough outcomes in human epidermal growth factor 2-positive and triple-negative breast cancers. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for other subtypes of the disease, including oestrogen receptor-positive breast cancer, which is a form of hormone receptor-positive breast cancer, the most prevalent type of all breast cancers.10,11 Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. References [1] Turner NC, et al. Inavolisib-Based Therapy in PIK3CA-Mutated Advanced Breast Cancer. NEJM. 2024;391(17):1584-96. [2] Fillbrunn M, et al. PIK3CA mutation status, progression and survival in advanced HR+/HER2- breast cancer: a meta-analysis of published clinical trials. BMC Cancer. 2022;22:1002. [3] Anderson E, et al. A Systematic Review of the Prevalence and Diagnostic Workup of PIK3CA Mutations in HR+/HER2– Metastatic Breast Cancer. Int J Breast Cancer. 2020;2020:3759179. [4] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer (INAVO120) [Internet; cited 2025 May]. Available from: https://classic.clinicaltrials.gov/ct2/show/NCT04191499. [5] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy (INAVO121) [Internet; cited 2025 May]. Available from: https://classic.clinicaltrials.gov/ct2/show/NCT05646862. [6] ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer (INAVO122) [Internet; cited 2025 May]. Available from: https://classic.clinicaltrials.gov/ct2/show/NCT05894239. [7] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer (INAVO123) [Internet; cited 2025 April]. Available from: https://clinicaltrials.gov/study/NCT06790693. [8] Juric D, et al. A phase I/Ib study of inavolisib (GDC-0077) in combination with fulvestrant in patients (pts) with PIK3CA-mutated hormone receptor-positive/HER2-negative (HR+/HER2–) metastatic breast cancer. Presented at San Antonio Breast Cancer Symposium, 2020 December 7-10; San Antonio, USA. Abstract #P5-17-05. [9] Hong R, et al. GDC-0077 is a selective PI3K alpha inhibitor that demonstrates robust efficacy in PIK3CA mutant breast cancer models as a single agent and in combination with standard of care therapies. Cancer Res. 2018;78(4):4-14. [10] National Cancer Institute: Surveillance, Epidemiology and Ends Result Program. Cancer Stat Facts: Female Breast Cancer Subtypes [Internet; cited 2025 April]. Available from: https://seer.cancer.gov/statfacts/html/breast-subtypes.html. [11] Lim E, et al. The natural history of hormone receptor-positive breast cancer. Oncology (Williston Park). 2012;26(8):688-94,696. [12] Tomas R and Barrios CH. Optimal management of hormone receptor positive metastatic breast cancer in 2016. Ther Adv Med Oncol. 2015;7(6):304-20. [13] Galipeau N, et al. Understanding key symptoms, side effects, and impacts of HR+/HER- advanced breast cancer: qualitative study findings. J Patient-Rep Outcomes. 2019;3(1):10. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultASCODrug Approval

23 May 2025

·firstwordpharma.com

Blenrep comeback continues with EU recommendation, plus a thumbs up for Itovebi

GSK's bid to bring back multiple myeloma therapy Blenrep (belantamab mafodotin) got a major boost on Friday when the antibody-drug conjugate (ADC) received a positive opinion from the EU's drug advisory panel. Also receiving a positive vote from the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) was Roche's breast cancer drug Itovebi (inavolisib). Survival data for the PI3K inhibitor was recently spotlighted in an abstract released ahead of the American Society of Clinical Oncology (ASCO) meeting (see – ASCO25 abstract roundup: Roche's Itovebi cuts risk of death).Autolus' CAR-T cell therapy Aucatzyl (obecabtagene autoleucel) also received a thumbs up from CHMP, as well as mirdametinib, a MEK inhibitor recently acquired by Merck KGaA in its $3.9-billion takeout of SpringWorks Therapeutics. Blenrep is backBlenrep was withdrawn from global markets in 2022 following disappointing results from a confirmatory trial, but after positive readouts from two pivotal Phase III trials — DREAMM-7 and DREAMM-8 — GSK has been working to bring the BCMA-targeted ADC back. Specifically, CHMP recommended Blenrep to treat relapsed or refractory multiple myeloma in combination with bortezomib and dexamethasone (BVd) for adults who have received at least one prior therapy; and in combination with Bristol Myers Squibb's Pomalyst (pomalidomide) plus dexamethasone for patients who have received at least one prior treatment, including BMS's Revlimid (lenalidomide). In DREAMM-7, Blenrep plus BVd achieved a progression-free survival (PFS) of 36.6 months, versus 13.4 months for the comparator regimen of Johnson & Johnson's Darzalex (daratumumab) plus BVd.DREAMM-8 compared Blenrep to bortezomib, both in combination with Pomalyst and dexamethasone. At nearly 22 months follow-up, median PFS was not yet reached with Blenrep compared to 12.7 months in the control arm.In April, the UK became the first country to reauthorise Blenrep. Regulatory applications for the ADC are under review in a dozen other countries, including the US, Switzerland, Japan, China and Canada. The FDA is expected to make a decision by July 23, although there is concern that recent mass layoffs at the FDA could slow down the review process (see – Spotlight On: Could key drug approvals be put at risk of delay by FDA layoffs?).GSK is positioning the drug as a key growth driver, projecting peak annual sales exceeding £3 billion (see – Spotlight On: Can GSK deliver much needed pipeline momentum?).Itovebi impressesItovebi scored a positive opinion for its use in combination with palbociclib and fulvestrant to treat PIK3CA‑mutated, ER‑positive/HER2‑negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment.The PI3K inhibitor won a similar approval in the US last October based on data from the Phase III INAVO120 study showing a 57% benefit for the Itovebi triplet on the primary endpoint of PFS compared to palbociclib and fulvestrant alone. Patients achieved PFS of 15 months in the experimental arm versus 7.3 months for placebo.At ASCO, Roche plans to share updated survival data for Itovebi. The abstract revealed that patients who received the triplet experienced a median overall survival of 34 months compared to 27 months for controls, representing a 33% reduction in the risk of death. Additionally, the combination therapy delayed the time to chemotherapy from 12.6 months in the control arm to 35.6 months with Itovebi.Go-ahead for Aucatzyl, mirdametinibA CHMP recommendation also went to Aucatzyl to treat patients aged 26 and older with relapsed or refractory B cell precursor acute lymphoblastic leukaemia (ALL).Autolus' CD19-directed cell therapy was cleared by the FDA in November for a similar indication, based on data from the Phase Ib/II FELIX trial. Of 65 patients with ALL who received the CAR-T, 27 (42%) achieved a complete response (CR) within three months, with a median CR duration of 14.1 months.Meanwhile, Merck KGaA's newly gained mirdametinib received a positive opinion to treat symptomatic, inoperable plexiform neurofibromas (PN) in paediatric and adult patients with neurofibromatosis type 1 (NF1) aged 2 years and above. If fully approved by the European Commission, it will have the brand name of Ezmekly.In February, the MEK inhibitor was approved in the US for the same patient population, where it's marketed as Gomekli.

Clinical ResultDrug ApprovalPhase 3AcquisitionASCO

22 May 2025

·firstwordpharma.com

ASCO25: Roche's Itovebi triplet cuts death risk by 33% in endocrine-resistant breast cancer

Roche's PI3K inhibitor Itovebi (inavolisib) has demonstrated a significant survival advantage in patients with PIK3CA-mutated, HR-positive/HER2-negative advanced breast cancer, according to new Phase III data to be presented at the upcoming American Society of Clinical Oncology (ASCO) meeting.Itovebi was approved by the FDA last October based on data from the INAVO120 study showing a 57% benefit on the primary endpoint of progression-free survival (PFS) when added to Pfizer's CDK 4/6 inhibitor Ibrance (palbociclib) and fulvestrant, compared to placebo plus Ibrance and fulvestrant alone. Patients achieved PFS of 15 months in the experimental arm versus 7.3 months for placebo.Results for the key secondary endpoint of overall survival (OS) were toplined earlier this year. At a pre-ASCO press briefing this week, lead author Nicholas Turner said patients receiving the triplet combination experienced a median OS of 34 months compared to 27 months for controls, representing a 33% reduction in the risk of death."This is the first time that overall survival has been improved by a PI3 kinase pathway targeted drug," Turner noted.Two-year delay in need for chemoBeyond the survival benefit, the triplet therapy delayed the time to chemotherapy from 12.6 months in the control arm to 35.6 months with Itovebi. "Delaying the need in the metastatic setting to go on chemotherapy by almost two years is certainly an outcome that matters to patients," commented Julie Gralow, chief medical officer at ASCO.Moreover, the previously reported PFS advantage was maintained with longer follow-up, showing a median PFS of 17.2 months versus 7.3 months in the placebo group.PI3K inhibitors have been dogged by safety concerns, although the adverse event (AE) profile in INAVO120 was "generally manageable," according to Turner. Serious AEs occurred in 27.3% of patients on the Itovebi regimen compared to 13.5% on placebo. However, Turner noted that only 6.8% of patients discontinued Itovebi due to side effects, suggesting that the side effects could be managed "overall" by doctors and their patients. For more, see – Physician Views Results: Doctors signal Itovebi's readiness to ignite Roche's oncology overhaul."We've been trying to develop PI3K inhibitors for many years, and what we've learned about it is the more specific and selective your drug can get for the mutant protein, the more effective it is because it minimises side effects," Turner said, adding that Itovebi "selectively degrades the mutant kinase, and this likely makes it more selective for breast cancer with the PIK3CA mutation, [maximising] the ability to hit PI3K in the tumour whilst relatively sparing normal cells."

Clinical ResultPhase 3ASCODrug Approval

100 Deals associated with Fulvestrant

External Link

KEGG	Wiki	ATC	Drug Bank
D01161	Fulvestrant	L02BA03	DB00947

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Hormone Receptor Positive Breast Adenocarcinoma	United States	AstraZeneca Pharmaceuticals LP	25 Aug 2017
Breast Cancer	Japan	AstraZeneca KK	26 Sep 2011
Estrogen receptor positive breast cancer	European Union	AstraZeneca AB	09 Mar 2004
Estrogen receptor positive breast cancer	Iceland	AstraZeneca AB	09 Mar 2004
Estrogen receptor positive breast cancer	Liechtenstein	AstraZeneca AB	09 Mar 2004
Estrogen receptor positive breast cancer	Norway	AstraZeneca AB	09 Mar 2004
Hormone receptor positive HER2 negative breast cancer	European Union	AstraZeneca AB	09 Mar 2004
Hormone receptor positive HER2 negative breast cancer	Iceland	AstraZeneca AB	09 Mar 2004
Hormone receptor positive HER2 negative breast cancer	Liechtenstein	AstraZeneca AB	09 Mar 2004
Hormone receptor positive HER2 negative breast cancer	Norway	AstraZeneca AB	09 Mar 2004
Hormone receptor positive breast cancer	United States	AstraZeneca Pharmaceuticals LP	25 Apr 2002

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
HER2 Positive Breast Cancer	Phase 3	Austria	Novartis Pharmaceuticals Corp.	14 Sep 2021
HER2 Positive Breast Cancer	Phase 3	France	Novartis Pharmaceuticals Corp.	14 Sep 2021
HER2 Positive Breast Cancer	Phase 3	Italy	Novartis Pharmaceuticals Corp.	14 Sep 2021
HER2 Positive Breast Cancer	Phase 3	Netherlands	Novartis Pharmaceuticals Corp.	14 Sep 2021
HER2 Positive Breast Cancer	Phase 3	Spain	Novartis Pharmaceuticals Corp.	14 Sep 2021
HER2 Positive Breast Cancer	Phase 3	Switzerland	Novartis Pharmaceuticals Corp.	14 Sep 2021
HER2-negative breast cancer	Phase 3	Italy	Novartis Pharmaceuticals Corp.	02 Feb 2018
Leukodystrophy, Hypomyelinating, 6	Phase 3	Italy	Novartis Pharmaceuticals Corp.	02 Feb 2018
Early Stage Breast Carcinoma	Phase 3	Spain	AstraZeneca PLC	01 Nov 2007
Solitary Fibrous Tumors	Phase 3	Canada	AstraZeneca PLC	01 Jan 2004

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO_BC2025	Not Applicable	HR+ \| HER2-negative	1,085	Fulvestrant	tjarxvaxdg(nakwkifjsb) = dlkavgickb jztwusltwu (hnynyobwpk ) View more	Negative	14 May 2025
NCT06408168 (REPLOT Trial, AACR2025)	Phase 2	E-cadherin \| ROS1	58	Repotrectinib	uinfmfqyvc(wnsdmgfuit) = <10% jilchactfg (yaxemdgzwx ) View more	Positive	29 Apr 2025
NCT06757634 (VIKTORIA-2, AACR2025)	Phase 3	Hormone receptor positive HER2 negative breast cancer First line PIK3CA	-	Gedatolisib + CDK4/6 inhibitor + Fulvestrant	dvjknslivj(ljtibegaew) = expected mPFS is 25 to 28 months jfxsdszhhw (dauelpetla ) View more	Positive	29 Apr 2025
NCT05169567 (postMONARCH, CTgov)	Phase 3	Hormone receptor positive HER2 negative breast cancer	368	Fulvestrant+abemaciclib (Arm A: Abemaciclib Plus Fulvestrant)	phdycygzhj(wkmrcrxfkg) = hkamhuobde jmswkgvzph (ijygxqeblt, uhvsuvpqaj - qnibwtqxsv) View more	-	27 Feb 2025
				Placebo+Fulvestrant (Arm B: Placebo Plus Fulvestrant)	phdycygzhj(wkmrcrxfkg) = jdvteaivtt jmswkgvzph (ijygxqeblt, yjmybfcgql - yducxisovq) View more
NCT04256941 (CTgov)	Phase 2	Metastatic breast cancer	4	Fulvestrant (Fulvestrant)	mfourobmpm(qgzzewkhrq) = qfyqviwofy osogagwxgv (mtcrqeghxi, tkmqjpabll - srbwjctrfa) View more	-	27 Dec 2024
				fulvestrant+ribociclib (Kisqali)+abemaciclib (verzenio)+palbociclib (Ibrance) (Continuing AI After Randomization)	mfourobmpm(qgzzewkhrq) = scqzlzyeib osogagwxgv (mtcrqeghxi, irpktteuaa - bnqmdhncil) View more
NCT02491983 (PARSIFAL, CTgov)	Phase 2	Metastatic HER2-Negative Breast Carcinoma \| ER-positive/HER2-negative Breast Cancer \| Metastatic breast cancer	486	Letrozole+palbociclib (Arm A)	zqtuejhyga = msuvooswhs cokhqcfydx (zbqcfcgefj, yywbzccjtu - ihmhbjhvqq) View more	-	09 Dec 2024
				Fulvestrant+palbociclib (Arm B)	zqtuejhyga = sawjwsqxsf cokhqcfydx (zbqcfcgefj, bgjdomhqhd - yzglvzzggt) View more
NCT04305496 (CAPItello-291, Pubmed \| J Clin Oncol)	Phase 3	PIK3CA mutation/HR-positive/HER2-negative Breast Cancer PIK3CA \| AKT1 \| PTEN	708	Capivasertib 400 mg twice daily with fulvestrant	hjfhatjykm(hpiklpjbsv): HR = 0.6 (95% CI, 0.51 - 0.71) View more	Positive	01 Dec 2024
				Placebo with fulvestrant
NCT02860000 (TBCRC041, CTgov)	Phase 2	Locally advanced breast cancer \| Metastatic breast cancer \| Hormone refractory breast cancer ... View more	96	Laboratory Biomarker Analysis+Alisertib (Arm I (Alisertib))	ltewzsngnx(nakcmwcebp) = cbhsphbwkv rwltpuailj (ovssdtpdkn, jiljbsvqsq - aygnptoozz) View more	-	18 Oct 2024
				Laboratory Biomarker Analysis+Alisertib+Fulvestrant (Arm II (Alisertib, Fulvestrant))	ltewzsngnx(nakcmwcebp) = mylfrmkryy rwltpuailj (ovssdtpdkn, iavxhvjqkr - xdvdaowyxz) View more
NCT02763566 (MONARCH plus, Pubmed \| Chin Med J (Engl)) Manual	Phase 3	Hormone receptor positive HER2 negative breast cancer Second line \| First line Hormone Receptor Positive \| HER2 Negative	-	Abemaciclib anastrozoleeroiletrozoletase inhibitor	kxquenwpdi(kcmssyahsl) = tcwiciacil mkbqcdssgs (yrvqxawzyp )	Positive	10 Oct 2024
				Placebo anastrozoleeroiletrozoletase inhibitor	kxquenwpdi(kcmssyahsl) = smornfwbtq mkbqcdssgs (yrvqxawzyp )
NCT02028507 (PEARL \| GEICAM/2013-02 PEARL \| PEARL study, CTgov)	Phase 3	Metastatic breast cancer \| Hormone receptor positive HER2 negative breast cancer	693	palbociclib+Exemestane (Cohort 1: Palbociclib Plus Exemestane)	zrjvqeavcy(otpjkhhtut) = dvcjfyglbu tpbgzvlybj (ikzvawwrwz, vfsgzpjnhi - gyfvanhcdk) View more	-	25 Sep 2024
				Fulvestrant+palbociclib (Cohort 2: Palbociclib Plus Fulvestrant)	zrjvqeavcy(otpjkhhtut) = klzlsrkexq tpbgzvlybj (ikzvawwrwz, icvlcilgxl - vvdvnbrhuk) View more

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