Clinical trials: Locally Advanced Unresectable HER2-Negative Breast Carcinoma
- Condition Locally Advanced Unresectable HER2-Negative Breast Carcinoma
- Funder type Industry (pharma, biotech, devices)
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
Locally Advanced or Unresectable Metastatic Breast Cancer, Stage IV Breast Cancer
Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy
The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available…
- Trial name
- ASCENT-07 (NCT05840211)
- Testing
- Sacituzumab Govitecan-hziy, Paclitaxel, Nab-paclitaxel
- Where
- 288 sites in United States, Argentina and 26 more
- Volunteers
- 654 people
- Sponsor
- Gilead Sciences
Breast Cancer
Efficacy and Safety Study of Disitamab Vedotin + RC148 vs. Albumin-Paclitaxone ± Toripalimab in HR-/HER2-low Breast Cancer
Evaluating the Efficacy of Disitamab Vedotin in Combination with RC148 Compared to Albumin-bound Paclitaxone Monotherapy or in Combination with Toripalimab for Subjects with HR-negative, HER2-low Expressing Unresectable Locally…
- Trial name
- NCT06642545
- Testing
- Disitamab Vedotin, RC148, Albumin-bound Paclitaxone
- Where
- China
- Volunteers
- 40 people
- Sponsor
- RemeGen Co., Ltd.
TNBC - Triple-Negative Breast Cancer, Breast Cancer
Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Metastatic Triple-Negative Breast Cancer (TNBC)
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of trilaciclib versus placebo administered prior to gemcitabine and carboplatin in patients receiving first- or…
- Trial name
- PRESERVE 2 (NCT04799249)
- Testing
- Trilaciclib, Gemcitabine, Carboplatin
- Where
- 71 sites in United States, Australia and 9 more
- Volunteers
- 194 people
- Sponsor
- G1 Therapeutics, 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.
Metastatic Breast Cancer
Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)
The purpose of this study is to assess the efficacy and safety of belzutifan (MK-6482) plus fulvestrant compared to everolimus plus endocrine therapy (ET) (investigator's choice of fulvestrant or exemestane) in adults with…
- Trial name
- NCT06428396
- Testing
- Belzutifan, Fulvestrant, Everolimus
- Where
- 41 sites in United States, Argentina and 7 more
- Volunteers
- 120 people
- Sponsor
- Merck Sharp & Dohme LLC
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.
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
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.
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
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.
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.
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.
Triple Negative Locally Advanced Non-resectable Breast Cancer, Metastatic Breast Cancer
Randomized Phase II Study of Ixabepilone Alone and Ixabepilone Plus Cetuximab as First-Line Treatment for Female Subjects With Triple Negative Locally Advanced Non-resectable and/or Metastatic Breast Cancer
The purpose of this study was to estimate the response rate of ixabepilone monotherapy, and the combination of ixabepilone plus cetuximab as first-line treatment of female subjects with triple negative (estrogen receptor [ER]…
- Trial name
- NCT00633464
- Testing
- ixabepilone, ixabepilone + cetuximab
- Where
- 19 sites in Austria, Czechia and 5 more
- Volunteers
- 79 people
- Sponsor
- R-Pharm
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
- 5 sites in United States
- Volunteers
- 63 people
- Sponsor
- Regor Pharmaceuticals Inc.
Triple Negative Breast Cancer
A Study of NK012 in Patients With Advanced, Metastatic Triple Negative Breast Cancer
The purpose of this study is to determine whether NK012 is safe and effective in the treatment of advanced and metastatic triple negative breast cancer.
- Trial name
- NCT00951054
- Testing
- NK012
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Nippon Kayaku Co., Ltd.
Breast Neoplasms
A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
Researchers are looking for other ways to treat breast cancer (BC) that is hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) and either unresectable locally advanced or metastatic.
- Trial name
- NCT07060807
- Testing
- Patritumab deruxtecan, Paclitaxel, Nab-paclitaxel
- Where
- 205 sites in United States, Argentina and 24 more
- Volunteers
- 1,000 people
- Sponsor
- Merck Sharp & Dohme LLC
Breast Cancer
A Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer
The open-label Phase Ib portion of this study will evaluate the safety and pharmacokinetics of ipatasertib in combination with palbociclib and fulvestrant to identify a dose of ipatasertib that can be combined with palbociclib…
- Trial name
- IPATunity150 (NCT04060862)
- Testing
- Ipatasertib, Palbociclib, Fulvestrant
- Where
- 20 sites in United States, Australia and 6 more
- Volunteers
- 20 people
- Sponsor
- Hoffmann-La Roche