Clinical trials: Locally Advanced Breast Carcinoma
Breast Neoplasms, Neoplasm Metastasis
Study Evaluating CCI-779 and Letrozole in Post-menopausal Women With Breast Cancer
In this clinical research study, postmenopausal subjects with metastatic breast cancer will be given either the combination of temsirolimus (CCI-779) and letrozole or a placebo and letrozole in first-line hormonal treatment.
- Trial name
- NCT00083993
- Testing
- Temsirolimus (CCI-779) for 34 months, Letrozole for 34 months
- Where
- 129 sites in United States, Canada
- Volunteers
- 1,236 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
HR Negative HER2 Positive Early Breast Cancer or Locally Advanced Breast Cancer Patients
Efficacy and Safety of the Proposed Biosimilar Pertuzumab (PERT-IJS) Versus EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Chemotherapy naïve Patients With Early Stage or Locally Advanced HR Negative and HER2 Positive Breast Cancer
To compare the efficacy and safety of PERT-IJS (Proposed biosimilar Pertuzumab) plus trastuzumab and chemotherapy (carboplatin and docetaxel) versus EU-Perjeta plus trastuzumab and chemotherapy (carboplatin and docetaxel) in…
- Trial name
- NCT06038539
- Testing
- PERT-IJS plus trastuzumab, carboplatin and docetaxel, Perjeta plus trastuzumab, carboplatin and docetaxel
- Where
- India
- Volunteers
- 55 people
- Sponsor
- Biocon Biologics UK Ltd
Triple-Negative Breast Cancer
A Clinical Study of 9MW2821 (and PD-1 Inhibitor) in Locally Advanced or Metastatic Triple-Negative Breast Cancer
This study is a Phase 2, open-label,multicenter study designed to evaluate the efficacy and safety of 9MW2821monotherapy or combined with PD-1 inhibitor in locally advanced or metastatic Triple-Negative Breast Cancer.
- Trial name
- NCT06492005
- Testing
- 9MW2821, PD-1 inhibitior
- Where
- China
- Volunteers
- 160 people
- Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
Breast Cancer
Real-World Outcomes of US Talazoparib-Treated Patients With Locally Advanced or Metastatic Breast Cancer
This study is a retrospective, multi-site, patient-level medical chart review of US adult patients with locally advanced or metastatic breast cancer (ABC) who initiated talazoparib on or after October 16, 2018 and were managed by…
- Trial name
- NCT04987931
- Testing
- Talazoparib
- Where
- United States
- Volunteers
- 84 people
- Sponsor
- Pfizer
Breast Cancer, Solid Tumor
To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer
This is an open-label, multicenter, Phase I study designed to evaluate the safety, tolerability, and pharmacokinetics of inavolisib administered orally as a single agent in patients with locally advanced or metastatic…
- Trial name
- NCT03006172
- Testing
- Inavolisib, Fulvestrant, Letrozole
- Where
- 12 sites in United States, Canada and 3 more
- Volunteers
- 200 people
- Sponsor
- Genentech, Inc.
Locally Advanced Solid Tumor
Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors
This is a first in human study in patients with advanced or metastatic solid tumors known to have an MTAP deletion. The first part of the study is an open-label, dose escalation and the second part is an open label dose expansion…
- Trial name
- NCT05732831
- Testing
- TNG462, Pembrolizumab
- Where
- 26 sites in United States, France and 1 more
- Volunteers
- 225 people
- Sponsor
- Tango Therapeutics, Inc.
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.
Breast Cancer, Non-small Cell Lung Carcinoma
DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer
This two-part study will include a dose escalation part to determine the recommended dose for expansion of DS8201a and pembrolizumab and a dose expansion part to evaluate efficacy, safety, and tolerability of the combination.
- Trial name
- NCT04042701
- Testing
- Trastuzumab deruxtecan (DS-8201a), Pembrolizumab
- Where
- 30 sites in United States, France and 2 more
- Volunteers
- 115 people
- Sponsor
- Daiichi Sankyo
Cancer
QUILT-3.013: Study of Ad5 [E1-, E2b-]-HER2/Neu Vaccine (ETBX-021) in Subjects With Unresectable Locally Advanced or Metastatic HER2-Expressing Breast Cancer
The purpose of this study is to determine whether ETBX-021 is safe and effective in the treatment of unresectable locally advanced or metastatic HER2-low-expressing breast cancer.
- Trial name
- NCT02751528
- Testing
- ETBX-021
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- NantBioScience, Inc.
Breast Cancer, Gastric/Gastroesophageal Junction Cancer
KN026 in Patients With HER2 Expressing Breast Cancer and Gastric Cancer
This is an open-label, phase 1 dose-escalation study of KN026 in subjects with HER2 positive advanced breast and Gastric Cancer. The standard "3 + 3" design was used for dose escalation.
- Trial name
- NCT03847168
- Testing
- KN026
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Locally Advanced or Metastatic Solid Tumor
A Study of Rebastinib (DCC-2036) in Combination With Carboplatin in Patients With Advanced or Metastatic Solid Tumors
This is an open-label Phase 1b/2 multicenter study of rebastinib (DCC-2036) in combination with carboplatin designed to evaluate the safety, tolerability, and pharmacokinetics (PK) in participants with advanced or metastatic…
- Trial name
- NCT03717415
- Testing
- Rebastinib, Carboplatin
- Where
- 9 sites in United States
- Volunteers
- 70 people
- Sponsor
- Deciphera Pharmaceuticals, LLC
Solid Tumor, Adult, Breast Cancer
PROCLAIM-CX-2009: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2009 for Patients With Selected Solid Tumors
The purpose of this first-in-human study of CX-2009 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-2009 in adult subjects with metastatic or locally advanced…
- Conditions
- Solid Tumor, Adult, Breast Cancer, Non Small Cell Lung Cancer, Head and Neck Cancer
- Trial name
- NCT03149549
- Testing
- CX-2009
- Where
- 26 sites in United States, Netherlands and 2 more
- Volunteers
- 99 people
- Sponsor
- CytomX Therapeutics
Expanded Access Use of Tucatinib for HER2+ Metastatic Breast Cancer
Physicians interested in requesting a single patient IND should contact Seattle Genetics' Medical Information (medinfo@seagen.com).
- Trial name
- NCT03424473
- Testing
- Tucatinib
- Sponsor
- Seagen Inc.
Breast Cancer
Safety and Pharmacokinetic Study of MM-302 in Patients With Advanced Breast Cancer
This study is a Phase 1 and pharmacologic open-label dose-escalation trial using a "3+3" design. Successive cohorts of three or more patients will be treated at escalating doses until a maximum tolerated dose is identified.
- Trial name
- NCT01304797
- Testing
- MM-302 Monotherapy, MM-302 in combination with trastuzumab, MM-302 in combination with trastuzumab q3w
- Where
- 5 sites in United States
- Volunteers
- 75 people
- Sponsor
- Merrimack Pharmaceuticals
Locally Advanced or Metastatic Solid Tumor(s), Prostate Cancer
A Study on the Safety of GEN1044 (DuoBody®-CD3x5T4) in Patients With Malignant Solid Tumors
The purpose of the trial is to evaluate the safety, determine the recommended Phase 2 dose (RP2D), and assess preliminary clinical activity of GEN1044 in patients with solid tumors.
- Conditions
- Locally Advanced or Metastatic Solid Tumor(s), Prostate Cancer, Esophageal Cancer, Triple Negative Breast Cancer (TNBC)
- Trial name
- NCT04424641
- Testing
- GEN1044 is an immunoglobulin G1 (IgG1) bispecific antibody targeting CD3 and 5T4.
- Where
- 6 sites in United States, Denmark and 2 more
- Volunteers
- 48 people
- Sponsor
- Genmab
Breast Cancer
Study of CR011-vcMMAE to Treat Locally Advanced or Metastatic Breast Cancer
This study will evaluate the safety and tolerability of CR011-vcMMAE in patients with locally advanced and metastatic breast cancer.
- Trial name
- NCT00704158
- Testing
- CR011-vcMMAE
- Where
- 5 sites in United States
- Volunteers
- 42 people
- Sponsor
- CuraGen Corporation
Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation
A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced or Metastatic Breast Cancer With a PIK3CA Mutation, After Disease Progression Following Endocrine Therapy as Monotherapy, in the Real-world Setting
This was a prospective, multi-national, non-interventional study (NIS) collecting data from postmenopausal women, and adult men, with HR+, HER2- locally advanced or metastatic breast cancer whose tumor harbors a PIK3CA mutation…
- Trial name
- NCT04967248
- Testing
- Alpelisib, Fulvestrant
- Volunteers
- 4 people
- Sponsor
- Novartis Pharmaceuticals
HER2-positive Breast Cancer
A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer
This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma.
- Trial name
- NCT03975647
- Testing
- tucatinib, T-DM1
- Where
- 490 sites in United States, Australia and 18 more
- Volunteers
- 466 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
Metastatic Breast Cancer or Metastatic Colorectal Cancer
A Bioequivalence Study of Capecitabine Tablets
1. purpose: To conduct the relative bioavalability study of Capecitabine tablets 500 mg (Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus XELODA® 500 mg tablets (Manufactured by Roche Pharma AG) 2.
- Trial name
- NCT01846650
- Testing
- Capecitabine tablets, XELODA
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group 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.