Clinical trials: ER-Positive HER2-Negative Breast Cancer
HER2-negative Breast Cancer
A Study to Investigate the Biological Effects of AZD9833 in Women With ER-positive, HER2 Negative Primary Breast Cancer
This is a randomised, open-label, parallel-group, pre-surgical study aimed to investigate the biological effects, safety, tolerability, and pharmacokinetics (PK) of different doses of oral AZD9833 in post-menopausal women with…
- Trial name
- SERENA-3 (NCT04588298)
- Testing
- AZD9833
- Where
- 12 sites in Georgia, Mexico and 1 more
- Volunteers
- 135 people
- Sponsor
- AstraZeneca
Breast Cancer Female
Letrozole in Post-Menopausal Patients With Operable Hormone-Sensitive Breast Cancer
A short pre-surgical non-therapeutic trial involving postmenopausal women with newly diagnosed eR+, HeR2-negative operable breast cancers.
- Trial name
- NCT03747042
- Testing
- Letrozole
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- University of Texas Southwestern Medical Center
ER Positive, Her2 Negative Breast Cancer Patients, Triple Negative Breast Cancer Patients
A Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer
To demonstrate whether addition of MM-121 to paclitaxel is more effective than treatment with paclitaxel alone, when administered as part of the neoadjuvant treatment in Her2 negative locally advanced operable breast cancer…
- Trial name
- NCT01421472
- Testing
- MM-121, Paclitaxel
- Where
- 38 sites in United States
- Volunteers
- 196 people
- Sponsor
- Merrimack Pharmaceuticals
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8
Mirvetuximab Soravtansine as First Line in Treating Patients With Triple Negative Breast Cancer
This phase II trial studies how well mirvetuximab soravtansine works as first line in treating patients with triple negative breast cancer.
- Conditions
- Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- Trial name
- NCT03106077
- Testing
- Mirvetuximab Soravtansine
- Where
- United States
- Volunteers
- 96 people
- Sponsor
- M.D. Anderson Cancer Center
Breast Cancer
A Study of Neoadjuvant Letrozole + Taselisib Versus Letrozole + Placebo in Post-Menopausal Women With Breast Cancer (LORELEI)
This is a two-arm, randomized, double-blind, multicenter, pre-operative study to evaluate the effect of combining letrozole and GDC-0032 (also known as taselisib) versus letrozole and placebo in postmenopausal women with estrogen…
- Trial name
- NCT02273973
- Testing
- Letrozole, Taselisib
- Where
- 117 sites in United States, Australia and 20 more
- Volunteers
- 334 people
- Sponsor
- Genentech, Inc.
Advanced Breast Cancer
Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR-positive, HER2-negative, Advanced Breast Cancer (aBC) With PIK3CA Mutation, Whose Disease Progressed on or After Endocrine Treatment
The purpose of this study was to determine the safety of alpelisib plus fulvestrant in men and post-menopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced or…
- Trial name
- ALPINIST (NCT05631795)
- Testing
- Alpelisib, Fulvestrant
- Where
- 12 sites in India
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)
The study will evaluate the safety and efficacy of datopotamab deruxtecan (also known as Dato-DXd, DS-1062a), when compared with Investigator's choice of standard of care single-agent chemotherapy (eribulin, capecitabine…
- Trial name
- NCT05104866
- Testing
- Dato-DXd, Capecitabine, Gemcitabine
- Where
- 167 sites in United States, Argentina and 18 more
- Volunteers
- 732 people
- Sponsor
- AstraZeneca
Breast Cancer
Docetaxel and Cyclophosphamide Compared to Anthracycline-Based Chemotherapy in Treating Women With HER2-Negative Breast Cancer
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of breast cancer cells, either by killing the cells or by stopping them from dividing.
- Trial name
- NCT01547741
- Testing
- Doxorubicin, Cyclophosphamide, Docetaxel
- Where
- 915 sites in United States, Puerto Rico
- Volunteers
- 4,242 people
- Sponsor
- NSABP Foundation Inc
Hormone Receptor Positive Breast Cancer
Open-label, Phase II, Study of Everolimus Plus Letrozole in Postmenopausal Women With ER+, HER2- Metastatic or Locally Advanced Breast Cancer
The purpose of this study was to assess the efficacy and safety of first-line treatment with everolimus plus letrozole in postmenopausal women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2…
- Trial name
- BOLERO-4 (NCT01698918)
- Testing
- Everolimus, Letrozole, Exemestane
- Where
- 52 sites in United States, Argentina and 11 more
- Volunteers
- 202 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Breast Cancer
A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Non-steroidal Aromatase Inhibitor
This study aimed at evaluating the safety and efficacy of everolimus plus exemestane in Chinese postmenopausal women with ER+ HER2- locally advanced, recurrent, or metastatic breast cancer after recurrence or progression on…
- Trial name
- BOLERO-5 (NCT03312738)
- Testing
- Everolimus, Exemestane
- Where
- 15 sites in China
- Volunteers
- 159 people
- Sponsor
- Novartis Pharmaceuticals
Breast Neoplasms, Breast Cancer
Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer
The primary purpose of phase 1 portion of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of H3B-6545 in women with locally advanced or metastatic estrogen receptor (ER)-positive…
- Conditions
- Breast Neoplasms, Breast Cancer, Estrogen-receptor Positive Breast Cancer, Cancer, Breast
- Trial name
- NCT03250676
- Testing
- H3B-6545
- Where
- 39 sites in United States, France and 1 more
- Volunteers
- 151 people
- Sponsor
- Eisai Inc.
Breast Cancer
Study of Elacestrant in Combination With Onapristone in Patients With Advanced or Metastatic Breast Cancer
This is a multicenter, Phase 1b-2 study of elacestrant in combination with onapristone in patients with advanced/metastatic ER+/PgR+/HER2- breast cancer.
- Trial name
- ELONA (NCT05618613)
- Testing
- Elacestrant, Onapristone
- Where
- 3 sites in United States
- Volunteers
- 4 people
- Sponsor
- Context Therapeutics Inc.
Breast Cancer
Use of Trastuzumab to Induce Increased ER Expression in ER-negative/Low, Her-2/Neu Positive Breast Cancer
The majority pf breast cancers present as ER-positive, many of which are able to be targeted with multiple hormonal therapies. Altering ER-negative tumors to increase ER expression has the potential to benefit patients by making…
- Trial name
- NCT00726180
- Testing
- trastuzumab (Herceptin®)
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of Michigan Rogel Cancer Center
Breast Cancer
A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer
This study is looking at whether Metformin, an agent that is commonly used to treat diabetes, can decrease or affect the ability of breast cancer cells to grow and whether Metformin will work with other therapies to keep cancer…
- Trial name
- NCT01101438
- Testing
- metformin hydrochloride
- Where
- 344 sites in United States, Canada and 2 more
- Volunteers
- 3,649 people
- Sponsor
- Canadian Cancer Trials Group
Metastatic Breast Cancer
Palbociclib in Molecularly Characterized ER-positive/HER2-negative Metastatic Breast Cancer
This international, multicenter, prospective single arm Phase II biomarker discovery clinical trial with the primary objective of assessing the association of PFS with gene mutations, gene copy number aberrations and gene…
- Trial name
- PYTHIA (NCT02536742)
- Testing
- Palbociclib, Fulvestrant
- Where
- 19 sites in Belgium, Italy and 1 more
- Volunteers
- 124 people
- Sponsor
- ETOP IBCSG Partners Foundation
Breast Cancer, Estrogen Receptor-positive Breast Cancer
Biology Guided Therapy for Breast Cancer for ER Positive
There are several approved and guideline-recommended treatments for metastatic, estrogen receptor-positive breast cancer that has progressed on an aromatase inhibitor and a CDK4/6 inhibitor.
- Conditions
- Breast Cancer, Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer
- Trial name
- SPOCK (NCT04965688)
- Testing
- Biopsy-Guided Therapy Selection
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Inova Health Care Services
Breast Cancer
Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer
The purpose of this study is to determine if ribociclib in combination with letrozole for 24 weeks as neoadjuvant endocrine therapy increases the proportion of women with Pre-operative Endocrine Prognostic Index (PEPI) score of 0…
- Trial name
- FELINE (NCT02712723)
- Testing
- Letrozole, Ribociclib
- Where
- 13 sites in United States
- Volunteers
- 121 people
- Sponsor
- Qamar Khan
Estrogen Receptor Negative, Estrogen Receptor Positive
MK2206 in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer
This phase II trial is studies how well Akt inhibitor MK2206 works in treating patients with stage I-III breast cancer that can be removed by surgery.
- Conditions
- Estrogen Receptor Negative, Estrogen Receptor Positive, HER2/Neu Negative, HER2/Neu Positive
- Trial name
- NCT01319539
- Testing
- Akt Inhibitor MK2206, Therapeutic Conventional Surgery, Pharmacological Study
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- National Cancer Institute (NCI)
Breast Carcinoma Metastatic in the Bone, Circulating Tumor Cell Count
Denosumab in Treating Patients With ER and/or PR Positive, HER2 Negative Metastatic Breast Cancer With Bone Metastases and Detectable Circulating Tumor Cells
The purpose of this study is to look at the amount of cancer cells in the blood of participants who are being treated with denosumab.
- Conditions
- Breast Carcinoma Metastatic in the Bone, Circulating Tumor Cell Count, Estrogen Receptor Positive, HER2/Neu Negative
- Trial name
- NCT03070002
- Testing
- Denosumab, Laboratory Biomarker Analysis
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- Northwestern University
Estrogen Receptor Positive, HER2/Neu Negative
FLT PET in Measuring Treatment Response in Patients With Newly Diagnosed Estrogen Receptor-Positive, HER2-Negative Stage I-III Breast Cancer
This clinical trial studies fluorine F 18 fluorothymidine (FLT) positron emission tomography (PET) in measuring treatment response in patients with newly diagnosed estrogen receptor (ER)-positive, human epidermal growth factor…
- Conditions
- Estrogen Receptor Positive, HER2/Neu Negative, Male Breast Carcinoma, Stage IA Breast Cancer
- Trial name
- NCT01928186
- Testing
- Fluorothymidine F-18, Positron Emission Tomography, Laboratory Biomarker Analysis
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- University of Washington