Clinical trials: Metastatic or Locally Advanced Breast Cancer
- Condition Metastatic or Locally Advanced Breast Cancer
- Funder type Industry (pharma, biotech, devices)
Breast Neoplasms
Study of the Pharmacokinetics and Safety of Trastuzumab Emtansine in Chinese Participants With Locally Advanced Inoperable or Metastatic HER2+ Breast Cancer
This is an open-label Phase I study of single-agent trastuzumab emtansine administered by intravenous (IV) infusion. The study will characterize the pharmacokinetics of trastuzumab emtansine and its relevant analytes and the…
- Trial name
- NCT03153163
- Testing
- Trastuzumab Emtansine
- Where
- China
- Volunteers
- 11 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of inavolisib in combination with fulvestrant compared with inavolisib in combination with fulvestrant in participants with PIK3CA-mutated, HR-positive…
- Trial name
- optINAVO (NCT07368998)
- Testing
- Inavolisib, Fulvestrant
- Where
- 34 sites in United States, Argentina and 6 more
- Volunteers
- 80 people
- Sponsor
- Hoffmann-La Roche
Advanced Breast Cancer, Breast Cancer
Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer
This is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced breast cancer.
- Trial name
- NCT00777101
- Testing
- Neratinib, Lapatinib, Capecitabine
- Where
- 152 sites in United States, Australia and 29 more
- Volunteers
- 233 people
- Sponsor
- Puma Biotechnology, Inc.
Breast Cancer
A Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in Advance Breast Cancer.
This was a three-arm, randomized, open label, multi-center phase II study investigating the combination of everolimus (10mg daily) with exemestane (25mg daily) versus everolimus (10mg daily) versus capecitabine (1250mg/m2 twice…
- Trial name
- BOLERO-6 (NCT01783444)
- Testing
- Capecitabine, Exemestane, Everolimus
- Where
- 83 sites in United States, Argentina and 16 more
- Volunteers
- 309 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy
This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with…
- Trial name
- SANDPIPER (NCT02340221)
- Testing
- Taselisib, Fulvestrant
- Where
- 157 sites in United States, Australia and 26 more
- Volunteers
- 631 people
- Sponsor
- Hoffmann-La Roche
Relapsed/Refractory Locally Advanced or Metastatic Breast Cancer and Triple Negative Breast Cancer
Safety Study of MELK Inhibitor to Treat Patients With Advanced Breast Cancer and Triple Negative Breast Cancer
The purpose of this study is to determine the maximum tolerated dose (MTD) of OTS167 administered via oral capsule (PO) to patients with relapsed/refractory locally advanced or metastatic breast cancer.
- Trial name
- NCT02926690
- Testing
- OTS167PO
- Where
- 8 sites in United States
- Volunteers
- 70 people
- Sponsor
- OncoTherapy Science, Inc.
Breast Cancer
Tesetaxel Plus Reduced Dose of Capecitabine in Patients With HER2 Negative, HR Positive, LA/MBC
CONTESSA 2 is a multinational, multicenter, Phase 2 study of tesetaxel in patients with HER2 negative, HR positive, locally advanced or metastatic breast cancer (LA/MBC) not previously treated with a taxane.
- Trial name
- CONTESSA 2 (NCT03858972)
- Testing
- Tesetaxel, Capecitabine
- Where
- 25 sites in United States, Australia and 4 more
- Volunteers
- 152 people
- Sponsor
- Odonate Therapeutics, Inc.
Breast Cancer, HER2 Positive Breast Cancer
Efficacy and Safety of IPI-504 With Trastuzumab Pretreated, Locally Advanced or Metastatic HER2 Positive Breast Cancer
The purpose of this study is to see if IPI-504 in combination with trastuzamab is an effective treatment in HER2 positive metastatic breast cancer
- Conditions
- Breast Cancer, HER2 Positive Breast Cancer, Metastatic Breast Cancer, Cancer of the Breast
- Trial name
- NCT00817362
- Testing
- IPI-504, Trastuzumab
- Where
- 11 sites in United States, Spain
- Volunteers
- 29 people
- Sponsor
- Infinity Pharmaceuticals, Inc.
HER2-Positive Solid Tumor
Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid Tumor
This first-in-human study will be counducted to evaluate the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of YH32367 in Patients with HER2-Positive Locally Advanced or Metastatic Solid Tumors.
- Trial name
- NCT05523947
- Testing
- YH32367
- Where
- 19 sites in United States, Australia and 1 more
- Volunteers
- 147 people
- Sponsor
- Yuhan Corporation
Metastatic Breast Cancer
PQR309 and Eribulin in Metastatic HER2 Negative and Triple-negative Breast Cancer (PIQHASSO)
This study is an open-label,non randomized, multi-center, phase 1/2b (dose escalation followed by expansion part) study evaluating clinical safety, efficacy and pharmacokinetics of PQR309 in combination with standard dose of…
- Trial name
- NCT02723877
- Testing
- PQR309, Eribulin
- Where
- 5 sites in Spain, United Kingdom
- Volunteers
- 41 people
- Sponsor
- PIQUR Therapeutics AG
Breast Cancer
HELENA Study: An Observational Study of Perjeta (Pertuzumab) in First-Line Treatment in Patients With Her2-Positive Advanced Breast Cancer After Adjuvant Herceptin Therapy
This observational study will evaluate the efficacy, safety and patient reported quality of life of palliative first-line Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) in patients with HER2-positive advanced…
- Trial name
- NCT01777958
- Where
- Germany
- Volunteers
- 135 people
- Sponsor
- Hoffmann-La Roche
Fatigue, Locally Advanced or Metastatic Breast Cancer
To Assess Efficacy and Safety of Oral Reparixin in Patients With Fatigue and Locally Advanced / Metastatic Breast Cancer
Primary objective: To assess the efficacy of reparixin compared to placebo in limiting CRF in adult patients with locally advanced or metastatic breast cancer undergoing single-agent taxane chemotherapy, using FACITFatigue scale.
- Trial name
- NCT05212701
- Testing
- Reparixin
- Where
- 20 sites in United States, Germany and 1 more
- Sponsor
- Dompé Farmaceutici S.p.A
Advanced HER2-positive Breast Cancer
Combination of AUY922 With Trastuzumab in HER2+ Advanced Breast Cancer Patients Previously Treated With Trastuzumab
The phase Ib part of the trial will assess the MTD of AUY922 in combination with Trastuzumab in patients with Trastuzumab-refractory locally advanced or metastatic HER2+.
- Trial name
- NCT01271920
- Testing
- AUY922, Trastuzumab
- Where
- 16 sites in United States, France and 6 more
- Volunteers
- 45 people
- Sponsor
- Novartis Pharmaceuticals
Cancer-related Fatigue
PG2 Injection for the Treatment of moderate-to Severe Fatigue in Breast Cancer Patients
The objective of this study is to assess the efficacy of weekly PG2 regimen as a complementary treatment for patients with recurrent unresectable (local or regional) or metastatic breast cancer who experienced moderate to severe…
- Trial name
- NCT05440227
- Testing
- PG2 Lyo. Injection 500mg
- Where
- Taiwan
- Volunteers
- 36 people
- Sponsor
- PhytoHealth Corporation
Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer
A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer)
This Phase III, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus everolimus compared with the physician's choice of endocrine therapy plus everolimus in participants with…
- Trial name
- NCT05306340
- Testing
- Giredestrant, Exemestane, Fulvestrant
- Where
- 136 sites in United States, Argentina and 11 more
- Volunteers
- 373 people
- Sponsor
- Genentech, Inc.
Urothelial Carcinoma, Renal Cell Carcinoma
Study of Cabozantinib Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
This is a multicenter Phase 1b, open-label study to assess safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of cabozantinib taken in combination with atezolizumab in subjects with multiple tumor types…
- Conditions
- Urothelial Carcinoma, Renal Cell Carcinoma, Non-Small Cell Lung Cancer, Castration-resistant Prostate Cancer
- Trial name
- NCT03170960
- Testing
- cabozantinib, atezolizumab
- Where
- 124 sites in United States, Australia and 7 more
- Volunteers
- 914 people
- Sponsor
- Exelixis
Advanced Solid Tumor, Advanced Malignant Neoplasm
The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C…
- Conditions
- Advanced Solid Tumor, Advanced Malignant Neoplasm, Metastatic Cancer, Metastatic Solid Tumor
- Trial name
- NCT04585750
- Testing
- rezatapopt, pembrolizumab
- Where
- 76 sites in United States, Australia and 7 more
- Volunteers
- 300 people
- Sponsor
- PMV Pharmaceuticals, Inc
Breast Neoplasms, BRCA 1 Gene Mutation
A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673), in Locally Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (ABRAZO Study)
The purpose of this 2-stage, 2-cohort Phase 2 trial is to evaluate the safety and efficacy of talazoparib (also known as BMN 673) in subjects with locally advanced or metastatic breast cancer with a deleterious germline BRCA 1 or…
- Conditions
- Breast Neoplasms, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
- Trial name
- ABRAZO (NCT02034916)
- Testing
- talazoparib
- Where
- 71 sites in United States, France and 3 more
- Volunteers
- 84 people
- Sponsor
- Pfizer
Breast Cancer, Renal Cell Carcinoma
Evaluation of IPI-549 Combined With Front-line Treatments in Pts. With Triple-Negative Breast Cancer or Renal Cell Carcinoma
MARIO-3 is a Phase 2 multi-arm combination cohort study designed to evaluate IPI-549, Infinity Pharmaceutical's first-in-class, oral immuno-oncology product candidate targeting immune-suppressive tumor-associated myeloid cells…
- Trial name
- MARIO-3 (NCT03961698)
- Testing
- IPI-549 (eganelisib), Atezolizumab, nab-paclitaxel
- Where
- 24 sites in United States
- Volunteers
- 91 people
- Sponsor
- Infinity Pharmaceuticals, Inc.
Breast Cancer
A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in participants with PIK3CA-mutant, hormone…
- Trial name
- INAVO120 (NCT04191499)
- Testing
- Inavolisib, Palbociclib, Fulvestrant
- Where
- 135 sites in United States, Argentina and 26 more
- Volunteers
- 325 people
- Sponsor
- Hoffmann-La Roche