Clinical trials: Early Stage Breast Cancer
Breast Cancer
Post Market Study Using the Xoft Axxent System
The purpose of this multi-center clinical study is to compile post market performance and safety data on the Axxent System.
- Trial name
- NCT01017549
- Testing
- Electronic brachytherapy (Axxent System)
- Where
- 10 sites in United States
- Volunteers
- 44 people
- Sponsor
- Xoft, Inc.
Early Breast Cancer
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Giredestrant Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer (coopERA Breast Cancer)
This is a randomized, multicenter, open-label, two-arm, Phase II study to evaluate the efficacy, safety, and pharmacokinetics of giredestrant versus anastrozole (in the window-of-opportunity phase) and giredestrant plus…
- Trial name
- NCT04436744
- Testing
- Giredestrant, Anastrozole, Palbociclib
- Where
- 65 sites in United States, Australia and 9 more
- Volunteers
- 221 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Study of Trastuzumab Emtansine (T-DM1) Sequentially With Anthracycline-based Chemotherapy, as Adjuvant or Neoadjuvant Therapy for Patients With Early Stage Herceptin (HER)2-positive Breast Cancer
This single-arm open-label study assessed the safety, feasibility, and efficacy of trastuzumab emtansine (T-DM1) after the completion of anthracycline-based adjuvant/neoadjuvant chemotherapy in patients with early HER2-positive…
- Trial name
- NCT01196052
- Testing
- Trastuzumab emtansine
- Where
- 44 sites in United States, Belgium and 6 more
- Volunteers
- 153 people
- Sponsor
- Hoffmann-La Roche
Neutropenia, Breast Cancer
SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE)
The purpose of this study was to compare the efficacy of a single dose of SPI-2012 versus pegfilgrastim in participants with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC), as measured by the duration of…
- Trial name
- ADVANCE (NCT02643420)
- Testing
- SPI-2012, Pegfilgrastim, Docetaxel
- Where
- 81 sites in United States, Canada and 1 more
- Volunteers
- 406 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Breast Cancer
Adj TC + Herceptin Early Stage Breast Cancer
The purpose of this research study is to find out what effects (good and bad) docetaxel/cyclophosphamide (brand names: Taxotere and Cytoxan, or TC) plus trastuzumab (brand name: Herceptin, or H) has HER2+ breast cancer.
- Trial name
- NCT00493649
- Testing
- Taxotere, Cytoxan, Herceptin
- Where
- 69 sites in United States
- Volunteers
- 493 people
- Sponsor
- US Oncology Research
Sexual Dysfunction, Physiological
Vaginal Testosterone Cream vs ESTRING for Vaginal Dryness or Decreased Libido in Early Stage Breast Cancer Patients
The purpose of this clinical research study is to determine whether the ESTRING or a special preparation of a testosterone cream inserted vaginally are safe for use in breast cancer patients.
- Trial name
- E-String (NCT00698035)
- Testing
- Testosterone Cream, Estring
- Where
- United States
- Volunteers
- 76 people
- Sponsor
- University of California, San Francisco
HER-2 Positive Breast Cancer, Breast Cancer
T-DM1+Pertuzumab in Pre-OP Early-Stage HER2+ BRCA
This research study is studying a combination of drugs as a possible treatment for breast cancer that has tested positive for a protein called HER2.
- Conditions
- HER-2 Positive Breast Cancer, Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer
- Trial name
- NCT02326974
- Testing
- T-DM1, Pertuzumab, Excision of tumor/mastectomy
- Where
- 4 sites in United States
- Volunteers
- 164 people
- Sponsor
- Dana-Farber Cancer Institute
Breast Cancer
Radiation Therapy in Treating Patients With Recurrent Breast Cancer
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. It is not yet known whether a single dose of radiation therapy is more effective than implant radiation therapy for 5 days in…
- Trial name
- NCT00945061
- Testing
- intracavitary balloon brachytherapy, intraoperative radiation therapy
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- Case Comprehensive Cancer Center
Breast Cancer
Single Dose Partial Breast Radiotherapy
This study seeks to determine the maximum tolerated dose of a single-dose partial breast radiation given before lumpectomy using a radiosurgery technique.
- Trial name
- RSU (NCT00944528)
- Testing
- Radiosurgery
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Duke University
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
Rifaximin for the Treatment of Gastrointestinal Toxicities Related to Pertuzumab-Based Therapy in Patients With Stage I-III HER2 Positive Breast Cancer
This phase II trial studies how well rifaximin works for the treatment of gastrointestinal toxicities related to pertuzumab-based therapy in patients with stage I-III HER2 positive breast cancer.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
- Trial name
- NCT04249622
- Testing
- Best Practice, Questionnaire Administration, Rifaximin
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Mayo Clinic
Breast Cancer
Single Fraction Elderly Breast Irradiation (SiFEBI)
Irradiation and Accelerated Partial Breast (IPAS) to this day remains a therapeutic concept whose validity is being assessed on its non-inferiority in terms of local control compared to whole breast irradiation.
- Trial name
- SIFEBI (NCT01727011)
- Testing
- IPAS
- Where
- France
- Volunteers
- 37 people
- Sponsor
- Centre Antoine Lacassagne
DCIS
Chemoprevention Trial - Anastrozole in Ductal Carcinoma In Situ (DCIS) in Postmenopausal Women
Breast cancer is one of the most common cancers seriously afflicting women in the United States. Of the one million incident cases that are reported annually there are approximately 193,000 new cases of breast cancer (Greenlee…
- Trial name
- NCT00256217
- Testing
- Anastrozole
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Rita Sanghvi, Mehta
Breast Cancer Stage II
Anlotinib Combined With Chemotherapy and Neoadjuvant Therapy for Hormone Receptor-positive HER-2 Negative Breast Cancer
Anlotinib is an oral multi-targeted tyrosine kinase inhibitor (TKI) that strongly inhibits VEGFR, PDGFR, FGFR, and c-kit. Combining anti-angiogenesis with chemotherapy yielded increased response rates in patients with early-stage…
- Trial name
- ACNTBC (NCT05558722)
- Testing
- Anlotinib
- Where
- China
- Volunteers
- 31 people
- Sponsor
- Xijing Hospital
Breast Cancer
Study of Amcenestrant (SAR439859) Versus Tamoxifen for Patients With Hormone Receptor-positive (HR+) Early Breast Cancer, Who Have Discontinued Adjuvant Aromatase Inhibitor Therapy Due to Treatment-related Toxicity
This was a phase III, randomized, double blind, multicenter, 2-arm study evaluating the efficacy and safety of amcenestrant compared with tamoxifen in participants with hormone receptor-positive early breast cancer who…
- Trial name
- AMEERA-6 (NCT05128773)
- Testing
- Amcenestrant, Tamoxifen
- Where
- 2 sites in Chile, China
- Volunteers
- 3 people
- Sponsor
- Sanofi
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Lung Non-Small Cell Carcinoma
Comparing Whole Brain Radiotherapy Using a Technique That Avoids the Hippocampus to Stereotactic Radiosurgery in Patients With Cancer That Has Spread to the Brain and Come Back in Other Areas of the Brain After Earlier Stereotactic Radiosurgery
This phase III trial compares the effect of adding whole brain radiotherapy with hippocampal avoidance and memantine versus stereotactic radiosurgery alone in treating patients with cancer that has spread to the brain and come…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Lung Non-Small Cell Carcinoma, Metastatic Lung Small Cell Carcinoma, Metastatic Malignant Breast Neoplasm
- Trial name
- NCT04588246
- Testing
- Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging
- Where
- 81 sites in United States, Canada and 1 more
- Volunteers
- 19 people
- Sponsor
- NRG Oncology
Breast Cancer
Study of Dose-dense Adriamycin Plus Cytoxan (AC) Followed by Either ABI-007 (Abraxane) or Taxol With Bevacizumab as Adjuvant Therapy for Patients With Breast Cancer
The primary objective of this study was to compare the safety of dose-dense ABI-007 (Abraxane) 260 mg/m^2 or Taxol 175 mg/m^2 given every 2 weeks following dose-dense Adriamycin plus Cytoxan (AC) chemotherapy.
- Trial name
- NCT00394251
- Testing
- Adriamycin and Cytoxan (AC), ABI-007, Taxol
- Where
- 27 sites in United States
- Volunteers
- 197 people
- Sponsor
- Celgene
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
Anastrozole and Letrozole After Surgery for the Treatment of Stage I-III Breast Cancer
This phase II trial studies how well anastrozole and letrozole after surgery work in treating patients with stage I-III breast cancer.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
- Trial name
- NCT04294225
- Testing
- Anastrozole, Letrozole
- Where
- 3 sites in United States
- Volunteers
- 161 people
- Sponsor
- Mayo Clinic
Breast Cancer, Breast Neoplasms
Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer
This is a Phase III, double-blind, randomized, multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of TX05 (trastuzumab) with Herceptin® in subjects with HER2 positive early breast cancer.
- Conditions
- Breast Cancer, Breast Neoplasms, HER2-positive Breast Cancer, Stage II Breast Cancer
- Trial name
- NCT03556358
- Testing
- TX05 (trastuzumab), Herceptin®, Paclitaxel
- Where
- 146 sites in Belarus, Chile and 8 more
- Volunteers
- 809 people
- Sponsor
- Tanvex BioPharma USA, Inc.
Invasive Breast Carcinoma, Stage I Breast Cancer AJCC v7
The Effect of Simvastatin on Breast Cancer Cell Growth in Women With Stage I-II Breast Cancer
The purpose of this pilot phase II trial is to identify the molecular and genetic mechanisms by which statins influence breast cancer cell proliferation.
- Conditions
- Invasive Breast Carcinoma, Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7
- Trial name
- NCT03454529
- Testing
- Laboratory Biomarker Analysis, Simvastatin
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Michael Simon
Breast Cancer
Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.
- Trial name
- ExteNET (NCT00878709)
- Testing
- neratinib
- Where
- 494 sites in United States, Australia and 38 more
- Volunteers
- 2,840 people
- Sponsor
- Puma Biotechnology, Inc.