Clinical trials: Advanced Unresectable or Metastatic Breast Cancer
- Condition Advanced Unresectable or Metastatic Breast Cancer
- Funder type Industry (pharma, biotech, devices)
Breast Cancer, HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer
A Study To Observe Treatment Patterns and Outcomes in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
This observational disease registry is a prospective, national, non-interventional study designed to enroll participants who have received an initial diagnosis of unresectable, locally advanced (LA) or metastatic breast cancer…
- Trial name
- NCT02616224
- Testing
- No intervention
- Sponsor
- Hoffmann-La Roche
Metastatic Breast Cancer, Locally Advanced Breast Cancer
A Phase I/II Study of FWD1802 in Patients With ER+/HER2- Advanced BC.
A Phase I/II, Open-label study to assess the safety, tolerability, pharmacokinetic, and antitumor efficacy of FWD1802 monotherapy in patients with ER+/HER2- unresectable locally advanced or metastatic breast cancer.
- Conditions
- Metastatic Breast Cancer, Locally Advanced Breast Cancer, Breast Cancer Stage IV, ER+/HER2- Breast Cancer
- Trial name
- NCT06064812
- Testing
- FWD1802
- Where
- 22 sites in China
- Volunteers
- 99 people
- Sponsor
- Forward Pharmaceuticals Co., Ltd.
Triple-Negative Breast Cancer (TNBC)
AK112 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/ Metastatic Triple-negative Breast Cancer
This multicenter, randomized, double-blind study aims to assess the safety and efficacy of AK112 in combination with Nab-Paclitaxel, compared to a placebo plus Nab-Paclitaxel, as a first-line treatment for inoperable locally…
- Trial name
- NCT06767527
- Testing
- AK112, Nab-paclitaxel
- Where
- China
- Volunteers
- 416 people
- Sponsor
- Akeso
Triple-negative Breast Cancer and HR+/HER2- BC
SKB264 +/- KL-A167 in Recurrent or Metastatic HER2-negative Breast Cancer
The purpose of this study is to assess the safety and tolerability and preliminary antitumor activity of SKB264 with/without KL-A167 in patients with unresectable locally advanced, recurrent or metastatic TNBC and HR+/HER2- BC…
- Trial name
- NCT05445908
- Testing
- SKB264, KL-A167
- Where
- 2 sites in China
- Volunteers
- 184 people
- Sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
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
HER2-positive Breast Cancer, HER2-positive Gastric Cancer
A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers
This study is designed to assess the safety and preliminary activity of SBT6050 in combination with trastuzumab deruxtecan (Part 1) or tucatinib plus trastuzumab +/- capecitabine (Part 2).
- Conditions
- HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER2-positive Colorectal Cancer, HER2-expressing Non-small Cell Lung Cancer
- Trial name
- NCT05091528
- Testing
- SBT6050, trastuzumab deruxtecan, tucatinib
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Silverback Therapeutics
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.
Advanced Breast Cancer
A Clinical Study of SYS6023 Combination Therapy for Advanced Breast Cancer
This is an open-label, multicenter Phase II clinical study conducted in subjects with advanced breast cancer.
- Trial name
- NCT07597629
- Testing
- SYS6023, KN026
- Where
- China
- Volunteers
- 36 people
- Sponsor
- CSPC Megalith Biopharmaceutical 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
Breast Cancer
Human Epidermal Growth Factor Receptor 2 (HER2) Positive Unresectable Locally Advanced or Metastatic Breast Cancer Disease Registry Study
This disease registry is a prospective, multicenter non-interventional study designed to observe the different anticancer treatment regimens and their sequencing throughout the course of the disease in participants with…
- Trial name
- ESTHER (NCT02393924)
- Testing
- No intervention
- Where
- 30 sites in United Kingdom
- Volunteers
- 311 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.
Triple Negative Breast Cancer, Inflammatory Breast Cancer Stage IV
Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With TNBC
This is an open label, single arm, multi-centre phase II study to assess the anti-tumour activity and safety of bemcentinib (BGB324) in combination with pembrolizumab in participants with previously treated, locally advanced and…
- Trial name
- NCT03184558
- Testing
- Bemcentinib; pembrolizumab
- Where
- 17 sites in United States, Norway and 2 more
- Volunteers
- 29 people
- Sponsor
- BerGenBio ASA
HR+HER2- 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(PANKU-Breast01)
This trial is a registered 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 after…
- Trial name
- NCT06343948
- Testing
- BL-B01D1, Eribulin, Vinorelbine
- Where
- China
- Volunteers
- 383 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
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.
Cancer, Advanced Cancer
A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors
AGX101 is an antibody-drug conjugate (ADC) therapy for tumor-forming cancers. The purpose of this study is to learn about AGX101 effects and safety at various dose levels in an all-comers advanced solid cancer patient population.
- Conditions
- Cancer, Advanced Cancer, Locally Advanced Carcinoma, Metastatic Solid Tumor
- Trial name
- NCT06440005
- Testing
- AGX101
- Where
- 7 sites in United States
- Volunteers
- 80 people
- Sponsor
- Angiex, Inc.
Clear Cell Renal Cell Cancer (ccRCC), Pancreatic Ductal Adenocarcinoma (PDAC)
A Study to Assess Safety, Tolerability and Imaging Characteristics of [68Ga]Ga-DPI-4452 and to Assess Safety, Tolerability, and Efficacy of [177Lu]Lu-DPI-4452 in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors
The main purpose of Part A of the study is to evaluate safety, tolerability and tracer uptake after a single intravenous (IV) administration of [68Ga]Ga-DPI-4452 for each tumor type such as clear cell renal cell cancer (ccRCC)…
- Conditions
- Clear Cell Renal Cell Cancer (ccRCC), Pancreatic Ductal Adenocarcinoma (PDAC), Colorectal Cancer (CRC), Urothelial Carcinoma (UC)
- Trial name
- NCT05706129
- Testing
- [68Ga]Ga-DPI-4452, [177Lu]Lu-DPI-4452
- Where
- 10 sites in Australia, France
- Volunteers
- 270 people
- Sponsor
- Lumara Bio Oncologics GmbH
Breast Cancer
A European Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced (LA) or Metastatic Breast Cancer (mBC) (SAMANTHA)
This disease registry is a prospective, multicenter non-interventional study designed to observe anti-cancer treatment regimens and clinical outcomes in participants with HER2-positive unresectable LA/mBC.
- Trial name
- NCT02913456
- Where
- 54 sites in Austria, Bulgaria and 3 more
- Volunteers
- 629 people
- Sponsor
- Hoffmann-La Roche
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.
Breast Cancer, Ovarian Cancer
Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors
This is a phase 1/1b, open-label, multicenter study consisting of sequential parts designed to evaluate the safety, tolerability, and effects pharmacokinetic (PK) profile, and antitumor activity of RGT-490, an investigational…
- Conditions
- Breast Cancer, Ovarian Cancer, Endometrial Cancer, PIK3CA Mutation
- Trial name
- NCT07524322
- Testing
- RGT-490
- Where
- 6 sites in United States
- Volunteers
- 63 people
- Sponsor
- Regor Pharmaceuticals Inc.
Breast Cancer
A Study of SI-B003 or BL-B01D1+SI-B003 in Patients With Unresectable Locally Advanced or Recurrent Metastatic HER2 Negative Breast Cancer
This phase II study is a clinical study to explore the efficacy and safety of SI-B003 monotherapy and BL-B01D1+SI-B003 combination therapy in patients with unresectable locally advanced or recurrent metastatic HER-2 negative…
- Trial name
- NCT06042894
- Testing
- BL-B01D1, SI-B003
- Where
- China
- Volunteers
- 58 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.