Clinical trials: Advanced Unresectable or Metastatic Breast Cancer
- Condition Advanced Unresectable or Metastatic Breast Cancer
- Funder type Industry (pharma, biotech, devices)
Breast Cancer Stage III, HER2-positive Metastatic Breast Cancer
Evaluate BL-M17D1 in Patients w/HER2-Expressing/Mutant Advanced or Metastatic Solid Tumors
The objective of this study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BL-M17D1 in patients with HER2-Expressing or HER2-Mutant Advanced or Metastatic Solid Tumors.
- Conditions
- Breast Cancer Stage III, HER2-positive Metastatic Breast Cancer, Unresectable Breast Carcinoma, Her2-Positive
- Trial name
- NCT06714617
- Testing
- BL-M17D1
- Where
- 9 sites in United States
- Volunteers
- 3 people
- Sponsor
- SystImmune Inc.
Locally Advanced (Inoperable) or Metastatic Breast Cancer
Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)
A Phase Ib/III Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative…
- Trial name
- CAPItello-292 (NCT04862663)
- Testing
- Capivasertib, Fulvestrant, Palbociclib
- Where
- 225 sites in United States, Argentina and 21 more
- Volunteers
- 893 people
- Sponsor
- AstraZeneca
Advanced Unresectable or Metastatic Breast Cancer of Adults
A Study of HRS-6208 in Combination With HRS-8080, or Fulvestrant, or Letrozole, With or Without HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer
This study aims to evaluate the safety, tolerability, efficacy and pharmacokinetics of HRS-6208 in combination with HRS-8080 ± HRS-6209, or in combination with fulvestrant ± HRS-6209, or in combination with letrozole ± HRS-6209…
- Trial name
- NCT07389733
- Testing
- HRS-6208 Capsule, HRS-6209 Capsule, HRS-8080 Tablet
- Where
- 2 sites in China
- Volunteers
- 180 people
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
HER2-expressing Cancers
A Dose Finding Study of ZW49 in Patients With HER2-Positive Cancers
This is a first-in-human, Phase 1, multicenter, open-label, dose-escalation study to establish the maximum-tolerated dose (MTD) or recommended dosage (RD) of ZW49, the investigational agent under study, and to assess the safety…
- Trial name
- NCT03821233
- Testing
- ZW49
- Where
- 16 sites in United States, Australia and 2 more
- Volunteers
- 112 people
- Sponsor
- Zymeworks BC Inc.
Solid Tumor, Adult, Colorectal Cancer
A Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated CAR T, in Participants With Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression
The goal of this study is to test A2B395, an allogeneic logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell…
- Conditions
- Solid Tumor, Adult, Colorectal Cancer, Non-Small Cell Lung, NSCLC (Non-small Cell Lung Cancer)
- Trial name
- DENALI-1 (NCT06682793)
- Testing
- A2B395, xT CDx with HLA-LOH assay
- Where
- 10 sites in United States
- Volunteers
- 240 people
- Sponsor
- A2 Biotherapeutics Inc.
HER2-positive Breast Cancer
DP303c in Patients With HER2-positive Unresectable Locally Advanced, Relapsed, or Metastaticbreast Cancer
This is a study of DP303c in patients with HER2-positive advanced breast cancer.
- Trial name
- NCT05334810
- Testing
- DP303c
- Volunteers
- 191 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Breast Neoplasms, Breast Cancer
Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009)
Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain breast cancers. The breast cancers being studied are HER2 positive unresectable locally advanced or metastatic (the cancer has spread to other parts…
- Trial name
- NCT06686394
- Testing
- Patritumab deruxtecan, Trastuzumab, Trastuzumab Biosimilar
- Where
- 18 sites in United States, Canada and 4 more
- Volunteers
- 181 people
- Sponsor
- Merck Sharp & Dohme LLC
Metastatic Breast Cancer
A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without Veliparib (ABT-888) in HER2-negative Metastatic or Locally Advanced Unresectable BRCA-associated Breast Cancer
The primary objective of the study is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin and paclitaxel (C/P) compared to placebo plus C/P in participants with a Breast Cancer Gene 1 or 2…
- Trial name
- NCT02163694
- Testing
- Veliparib, Carboplatin, Paclitaxel
- Where
- 219 sites in United States, Argentina and 35 more
- Volunteers
- 513 people
- Sponsor
- AbbVie
HER2 Positive Breast Cancer
A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer
This trial studies how well the drug tucatinib works when given with trastuzumab deruxtecan (T-DXd). It will also look at what side effects happen when these drugs are given together.
- Trial name
- HER2CLIMB-04 (NCT04539938)
- Testing
- tucatinib, trastuzumab deruxtecan
- Where
- 140 sites in United States
- Volunteers
- 70 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
Breast Cancer
Paclitaxel With or Without Gemcitabine in Treating Women With Advanced Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
- Trial name
- NCT00006459
- Testing
- gemcitabine hydrochloride, paclitaxel
- Where
- 31 sites in United States
- Sponsor
- Eli Lilly and Company
Breast Cancer
FS-1502 Versus T-DM1 for HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
This study is designed to compare the anti-tumor activity as well as the safety and efficacy of FS-1502 versus T-DM1 in HER2-positive, unresectable locally advanced or metastatic breast cancer subjects previously treated with…
- Trial name
- NCT05755048
- Testing
- Investigational drug: Recombinant Anti-HER2 Humanized Monoclonal Antibody - Monomethyl Auristatin F Conjugates for Injection (FS-1502), Control drug: Trastuzumab emtansine (Kadcyla, T-DM1)
- Where
- 56 sites in China
- Volunteers
- 314 people
- Sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Breast Cancer
A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+/HER2- Breast Cancer After Failure of Prior Endocrine Therapy(PANKU-Breast03)
This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer…
- Trial name
- NCT07648914
- Testing
- BL-B01D1, Albumin-Bound Paclitaxel, Paclitaxel
- Where
- China
- Volunteers
- 446 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Locally Advanced Non-resectable Breast Cancer, Metastatic Breast Cancer
Tesetaxel Every 3 Weeks vs Weekly vs Capecitabine as 1st-line Therapy for Locally Advanced or Metastatic Breast Cancer
This study is being conducted to compare the efficacy and safety of tesetaxel administered once every 3 weeks in a 21-day cycle, tesetaxel administered once weekly for 3 consecutive weeks in a 28-day cycle, and capecitabine…
- Trial name
- NCT01609127
- Testing
- Tesetaxel, Capecitabine
- Where
- United States
- Volunteers
- 213 people
- Sponsor
- Genta Incorporated
Advanced or Metastatic Breast Cancer
MEN1611 With Trastuzumab (+/- Fulvestrant) in Metastatic Breast Cancer
The main purpose of this open-label, dose-escalation, phase Ib study is to identify the appropriate dose of MEN1611 to be used in combination with Trastuzumab with/without Fulvestrant for the treatment of advanced or metastatic…
- Trial name
- B-PRECISE-01 (NCT03767335)
- Testing
- MEN1611, Trastuzumab, Fulvestrant
- Where
- 27 sites in United States, Belgium and 4 more
- Volunteers
- 62 people
- Sponsor
- Menarini Group
Advanced Breast Cancer
A Study of Vinflunine Plus Gemcitabine Versus Paclitaxel Plus Gemcitabine in Patients With Advanced Breast Cancer
The combination of vinflunine and gemcitabine in advanced breast cancer in comparison to paclitaxel and gemcitabine is based on the following points: the significant antitumour activity of vinflunine in metastatic breast cancer…
- Trial name
- VICTORIA (NCT02054338)
- Testing
- Vinflunine+Gemcitabine, Paclitaxel+Gemcitabine
- Volunteers
- 1,004 people
- Sponsor
- Pierre Fabre Medicament
Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast
A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations
This is an open-label, multi-center, single arm, Phase II study to evaluate the efficacy and safety of T-DXd for the treatment of unresectable and/or metastatic solid tumors harboring specific HER2 activating mutations regardless…
- Trial name
- DPT01 (NCT04639219)
- Testing
- Trastuzumab deruxtecan
- Where
- 30 sites in United States, Belgium and 7 more
- Volunteers
- 102 people
- Sponsor
- AstraZeneca
HR Positive/HER2 Negative Advanced or Metastatic Breast Cancer
A Phase III Clinical Trial of NTQ1062 in Combination With Fulvestrant for the Treatment of Advanced or Metastatic HR+/HER2- Breast Cancer
NTQ1062-301 is a randomized, double-blind, placebo-controlled Phase III clinical trial to evaluate the efficacy and safety of the small-molecule AKT inhibitor NTQ1062 combined with fulvestrant versus placebo combined with…
- Trial name
- NCT07393321
- Testing
- NTQ1062+Fulvestrant
- Volunteers
- 210 people
- Sponsor
- Nanjing Chia-tai Tianqing Pharmaceutical
HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer
A Study of Trastuzumab Emtansine in Indian Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Treatment With Trastuzumab and a Taxane
This is a Phase IV, single-arm, multicenter, open-label clinical trial designed to assess the safety of trastuzumab emtansine in Indian patients with HER2-positive unresectable locally advanced breast cancer (LABC) or metastatic…
- Trial name
- NCT02658734
- Testing
- Trastuzumab emtansine
- Where
- 13 sites in India
- Volunteers
- 70 people
- Sponsor
- Hoffmann-La Roche
HER2-positive Breast Cancer
A Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer
This study is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable locally advanced or metastatic HER2-positive breast cancer who had…
- Trial name
- NCT06316531
- Testing
- BL-M07D1, T-DM1
- Where
- China
- Volunteers
- 274 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
HER2-positive Breast Cancer, HER2-low Breast Cancer
A Study to Assess the Effectiveness of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)
This multi-center observational prospective study will collect real-world clinical and patient-reported outcome data from eligible patients with unresectable or metastatic HER2+ breast cancer who have received one or more prior…
- Conditions
- HER2-positive Breast Cancer, HER2-low Breast Cancer, Breast Cancer, Advanced Cancer
- Trial name
- NCT06210776
- Testing
- Trastuzumab deruxtecan
- Where
- 54 sites in China
- Volunteers
- 800 people
- Sponsor
- Daiichi Sankyo