Clinical trials: Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer
- Condition Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer
- Funder type Industry (pharma, biotech, devices)
Breast Cancer, Hormone-receptor-positive Breast Cancer
A Phase 1/1b Study of PRT13722 in Participants With Advanced HR+/HER2- Breast Cancer
This first-in-human, open-label, multicenter study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of PRT13722, an oral KAT6A protein degrader, in adults with locally…
- Conditions
- Breast Cancer, Hormone-receptor-positive Breast Cancer, HER2-negative Breast Cancer, HR-positive Breast Cancer
- Trial name
- NCT07905001
- Testing
- PRT13722, Fulvestrant, Abemaciclib
- Volunteers
- 242 people
- Sponsor
- Prelude Therapeutics Incorporated
Advanced Solid Tumor, Advanced Breast Cancer
BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors
This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in…
- Conditions
- Advanced Solid Tumor, Advanced Breast Cancer, Metastatic Breast Cancer, Hormone-receptor-positive Breast Cancer
- Trial name
- NCT06120283
- Testing
- BGB-43395, Fulvestrant, Letrozole
- Where
- 61 sites in United States, Australia and 9 more
- Volunteers
- 433 people
- Sponsor
- BeOne Medicines
Metastatic Breast Cancer, HER2-negative Breast Cancer
Trial of 225Ac-DOTATATE (RYZ101) in Subjects With ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs.
Phase 1b/2 open-label trial of 225Ac-DOTATATE (RYZ101) in subjects with ER+, HER2-negative unresectable or metastatic breast cancer expressing SSTRs.
- Conditions
- Metastatic Breast Cancer, HER2-negative Breast Cancer, ER+ Breast Cancer, Advanced Breast Cancer
- Trial name
- TRACY-1 (NCT06590857)
- Testing
- RYZ101, Standard of Care Endocrine Therapy
- Where
- 31 sites in United States, Canada and 1 more
- Volunteers
- 64 people
- Sponsor
- RayzeBio, Inc.
PIK3CA Mutation, HER2- Negative Breast Cancer
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 (zovegalisib) + fulvestrant to capivasertib + fulvestrant for the treatment of patients with HR+/HER2- ABC with…
- Conditions
- PIK3CA Mutation, HER2- Negative Breast Cancer, Hormone Receptor Positive Tumor, Breast Cancer
- Trial name
- ReDiscover-2 (NCT06982521)
- Testing
- Zovegalisib, Capivasertib, Fulvestrant
- Where
- 243 sites in United States, Argentina and 25 more
- Volunteers
- 540 people
- Sponsor
- Relay Therapeutics, Inc.
Hormone-receptor-positive Breast Cancer, HER2-negative Breast Cancer
BGB-21447 (Bcl-2 Inhibitor) Combinations for Adults With Hormone-Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer
This is a dose escalation and dose expansion study to assess the safety and tolerability of BGB-21447 (a B-cell leukemia/lymphoma 2 inhibitor, Bcl-2i) in combination with fulvestrant, with or without BGB-43395 (cyclin-dependent…
- Conditions
- Hormone-receptor-positive Breast Cancer, HER2-negative Breast Cancer, Metastatic Breast Cancer
- Trial name
- NCT06756932
- Testing
- BGB-21447, Fulvestrant, BGB-43395
- Where
- 14 sites in United States, Australia and 1 more
- Volunteers
- 120 people
- Sponsor
- BeOne Medicines
Advanced Solid Tumor, Metastatic Solid Tumor
BGB-43395 Alone or as Part of Combination Therapies in Chinese Participants With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
This is an open-label, multicenter, phase 1a/1b clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-43395, a cyclin-dependent kinase 4 (CDK4)…
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor, Hormone-receptor-positive Breast Cancer, Breast Cancer
- Trial name
- NCT06253195
- Testing
- BGB-43395, Fulvestrant, Letrozole
- Where
- 7 sites in China
- Volunteers
- 33 people
- Sponsor
- BeOne Medicines
Hormone Receptor-positive Breast Cancer, HER2-negative Breast Cancer
ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer
This is a multicenter, open-label, non-controlled, phase I study to investigate the tolerability and safety of ONO-4578 used in combination with standard-of-care letrozole and a CDK4/6 inhibitor (palbociclib or Abemaciclib) as…
- Conditions
- Hormone Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer
- Trial name
- NCT06570031
- Testing
- ONO-4578, letrozole, Palbociclib
- Where
- 13 sites in Japan
- Volunteers
- 46 people
- Sponsor
- Ono Pharmaceutical Co., Ltd.
PIK3CA Mutation, Solid Tumor, Adult
First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors
This is a Phase 1, first-in-human, open-label study designed to evaluate the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor…
- Conditions
- PIK3CA Mutation, Solid Tumor, Adult, HER2-negative Breast Cancer, Breast Cancer
- Trial name
- NCT05759949
- Testing
- RLY-5836, Fulvestrant, Palbociclib
- Where
- 7 sites in United States
- Volunteers
- 41 people
- Sponsor
- Relay Therapeutics, Inc.
Advanced Solid Tumors, Metastatic Colon Cancer
A Multi-Center, Open-Label Study of Fruquintinib in Solid Tumors and Colorectal, and Breast Cancers
An open-label, dose escalation and expansion clinical trial to evaluate the safety, tolerability, and PK of fruquintinib in patients with advanced solid tumors, metastatic colorectal cancer and metastatic breast cancer.
- Conditions
- Advanced Solid Tumors, Metastatic Colon Cancer, Metastatic Breast Cancer, Triple Negative Breast Cancer
- Trial name
- NCT03251378
- Testing
- Fruquintinib (HMPL-013)
- Where
- 9 sites in United States
- Volunteers
- 129 people
- Sponsor
- Hutchison Medipharma Limited
Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer, Metastatic Cervical Cancer
HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib
This is a multi-center, observational genomic screening protocol to identify participants whose tumors harbor somatic mutations in the ERBB2 (HER2) gene, as measured in circulating tumor DNA (ctDNA) .
- Trial name
- NCT03786107
- Testing
- Almac HER-Seq Assay
- Where
- 22 sites in United States, France and 5 more
- Volunteers
- 1,583 people
- Sponsor
- Puma Biotechnology, Inc.
Dose Escalation, Safety
Phase Ib, Dose Escalation Study of Oral LDE225 in Combination With BKM120 in Patients With Advanced Solid Tumors
The purpose of this study is to determine the maximum dose of LDE225 and BKM120 that can be safely given together to patients and/or the dose that will be used in future studies.
- Conditions
- Dose Escalation, Safety, Preliminary Efficacy, Advanced Solid Tumors
- Trial name
- NCT01576666
- Testing
- LDE225, BKM120
- Where
- 23 sites in United States, Australia and 6 more
- Volunteers
- 120 people
- Sponsor
- Novartis Pharmaceuticals