Clinical trials: Advanced Unresectable or Metastatic Breast Cancer
- Condition Advanced Unresectable or Metastatic Breast Cancer
- Funder type Industry (pharma, biotech, devices)
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
Breast Cancer
Study of Icrucumab (IMC-18F1) or Ramucirumab Drug Product (DP) in Combination With Capecitabine or Capecitabine on Previously Treated Breast Cancer Patients
An open-label, multicenter, randomized, Phase 2 trial in which participant with unresectable, locally advanced or metastatic breast cancer who have been previously treated with anthracycline and taxane therapy receive ramucirumab…
- Trial name
- NCT01234402
- Testing
- Ramucirumab DP, IMC-18F1, Capecitabine
- Where
- 23 sites in United States, Canada
- Volunteers
- 153 people
- Sponsor
- Eli Lilly and Company
Metastatic Breast Cancer
A Study of SKB264 Versus Investigator's Choice of Chemotherapy in Subjects With Unresectable Locally Advanced, Relapsed, or Metastatic HR+/HER2- Breast Cancer Who Have Previously Failed Endocrine Therapy
The purpose of this study is to evaluate the efficacy and safety of SKB264 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer who have previously failed endocrine therapy.
- Trial name
- NCT07071337
- Testing
- SKB264, Nab-paclitaxel, Paclitaxel
- Where
- 2 sites in China
- Volunteers
- 430 people
- Sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
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
HER2-positive Breast Cancer
IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer
This is a randomized, multicenter, open-label, phase 3 study evaluating the efficacy, safety, and tolerability of IBI354 combined with or without pertuzumab vs.
- Trial name
- NCT07377643
- Testing
- Trastuzumab, IBI354, Docetaxel
- Where
- China
- Volunteers
- 540 people
- Sponsor
- Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
Triple Negative Breast Cancer
A Phase III Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Triple-Negative Breast Cancer Who Have Failed Standard of Care
Primary Endpoint of this Study: To compare Progression-Free Survival (PFS) (as assessed by a Blinded Independent Review Committee [BIRC] based on Response Evaluation Criteria in Solid Tumors [RECIST v1.1]) between JSKN016 and…
- Trial name
- NCT07533123
- Testing
- JSKN016 Injection, Eribulin Mcsilate Injection, Vinorelbine Tartrate Injection
- Where
- China
- Volunteers
- 364 people
- Sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Breast Cancer, Triple Negative Breast Cancer
A Phase 3 Study Comparing Carelizumab Plus Nab-paclitaxel and Apatinib, Carelizumab Plus Nab-paclitaxel, and Nab-paclitaxel in Patients With Advanced Triple Negative Breast Cancer.
This randomized, open-label phase 3 study will evaluate the safety and efficacy of Carelizumab (an engineered anti-programmed death-ligand 1 [PD-1] antibody) in combination with Nab-paclitaxel and Apatinib, carelizumab plus…
- Trial name
- NCT04335006
- Testing
- Carelizumab, Nab-paclitaxel, Apatinib
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
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
Breast Cancer
A Study of Tobemstomig + Nab-Paclitaxel Compared With Pembrolizumab + Nab-Paclitaxel in Participants With Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer
The purpose of this study is to assess the efficacy and safety of a novel immunotherapy candidate, tobemstomig, in combination with nab-paclitaxel, for patients with previously untreated, locally advanced, unresectable or…
- Trial name
- NCT05852691
- Testing
- Tobemstomig, Pembrolizumab, Nab-Paclitaxel
- Where
- 37 sites in United States, Argentina and 14 more
- Volunteers
- 83 people
- Sponsor
- Hoffmann-La Roche
Melanoma, Non-small Cell Lung Cancer
A Study of CDX-1140 (CD40) as Monotherapy or in Combination in Patients With Advanced Malignancies
This is a study to determine the maximum tolerated dose (MTD) for CDX-1140 (CD40 antibody), either alone or in combination with CDX-301 (FLT3L), pembrolizumab, or chemotherapy and to further evaluate its tolerability and efficacy…
- Conditions
- Melanoma, Non-small Cell Lung Cancer, Breast Cancer, Gastric Cancer
- Trial name
- NCT03329950
- Testing
- CDX-1140, CDX-301, pembrolizumab
- Where
- 11 sites in United States
- Volunteers
- 132 people
- Sponsor
- Celldex Therapeutics
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.
HER2-expressing Cancers
Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers
This is a first-in-human, 3-part study to investigate the safety, tolerability, and effectiveness of ZW25 (zanidatamab) by itself and combined with selected chemotherapy agents in patients with locally advanced (unresectable)…
- Trial name
- NCT02892123
- Testing
- ZW25 (Zanidatamab), Paclitaxel, Capecitabine
- Where
- 17 sites in United States, Canada and 1 more
- Volunteers
- 279 people
- Sponsor
- Jazz Pharmaceuticals
Triple Negative Breast Cancer
Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer
This was a Phase 2, multicenter, open-label, single-arm study evaluating the safety and efficacy of trilaciclib administered prior to sacituzumab govitecan-hziy in participants with unresectable, locally advanced or metastatic…
- Trial name
- NCT05113966
- Testing
- Trilaciclib, Sacituzumab Govitecan-hziy
- Where
- 22 sites in United States
- Volunteers
- 30 people
- Sponsor
- G1 Therapeutics, Inc.
Metastatic Breast Cancer, Breast Cancer Stage I
A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC
This is a Study to Evaluate the Efficacy and Safety of Multiple Combination Therapies with FWD1802 in Subjects with ER-positive/HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer
- Conditions
- Metastatic Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Locally Advanced Breast Cancer (LABC)
- Trial name
- NCT07002177
- Testing
- FWD1802, Palbociclib 125mg, Ribociclib 200Mg Oral Tablet
- Where
- China
- Volunteers
- 196 people
- Sponsor
- Forward Pharmaceuticals 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
Uterine Cervical Neoplasms, Triple Negative Breast Neoplasms
A Phase II Study of GV20-0251 in Combination With Anti-PD-1 Monoclonal Antibodies in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors.
This is a Phase 2 study of GV20-0251 in combination with anti-PD-1 monoclonal antibodies (including tislelizumab and toripalimab) for the treatment of participants with unresectable, locally advanced, or metastatic solid tumors…
- Conditions
- Uterine Cervical Neoplasms, Triple Negative Breast Neoplasms, Prostatic Neoplasms, Squamous Cell Carcinoma of Head and Neck
- Trial name
- NCT07623642
- Testing
- GV20-0251, anti-PD-1 monoclonal antibodies
- Where
- 2 sites in China
- Volunteers
- 227 people
- Sponsor
- GV20 Therapeutics
Advanced Unresectable or Metastatic Breast Cancer
A Trial of HRS-2189 in Combination With Fluvastatin±HRS-6209, or HRS-8080±HRS-6209, or HRS-6209+HRS-1358 in Breast Cancer Patients
The study is being conducted to evaluate the efficacy, and safety of dexmedetomidine hydrochloride nasal spray for preoperative sedation in adults.
- Trial name
- NCT06679036
- Testing
- HRS-2189, Fluvustat, HRS-8080
- Where
- 2 sites in China
- Volunteers
- 300 people
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Triple Negative Locally Advanced Non-resectable Breast Cancer, HR+, HER2-, Advanced Breast Cancer
A Study of Invikafusp Alfa (STAR0602), a Selective T Cell Receptor (TCR)-Targeting, Bifunctional Antibody-fusion Molecule, in Combination With Sacituzumab Govitecan in Participants With Advanced Solid Tumors
This is a Phase 1b/2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp alfa (STAR0602), a Selective T Cell Receptor (TCR)-targeting, Bifunctional Antibody-fusion Molecule, in Combination with Sacituzumab…
- Trial name
- START-002 (NCT06827613)
- Testing
- STAR0602, Sacituzumab Govitecan (SG)
- Where
- 8 sites in United States, Canada
- Volunteers
- 50 people
- Sponsor
- Marengo Therapeutics, Inc.
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.
Breast Cancer, Solid Tumor
A Study of BL-B01D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors
In this study, the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), recommended phase II dose (RP2D), the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of BL-B01D1 will be investigated in…
- Trial name
- NCT05470348
- Testing
- BL-B01D1
- Where
- 2 sites in China
- Volunteers
- 36 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.