Clinical trials: Early-Stage Invasive Breast Carcinoma
Carcinoma, Ductal, Breast
Phase II Trial to Validate Markers for a Response Evaluation of a Combined Therapy in Patients With HER2+ Breast Cancer
The Neo-PREDICT-HER2 Study is phase II trial to validate predictive markers for the response evaluation of a combined chemo-immunotherapy in patients with HER2-positive early breast cancer.
- Trial name
- NCT01891357
- Testing
- Biopsy before and after three weeks of study treatment, paclitaxel, lapatinib
- Where
- 10 sites in Germany
- Volunteers
- 64 people
- Sponsor
- Women's Cancer Study Group GmbH
Breast Cancer
MRI in Evaluating Early Response to Chemotherapy in Women With Infiltrating Breast Cancer
RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI), may help in learning how well chemotherapy works to kill breast cancer cells and allow doctors to plan better treatment.
- Trial name
- ISNA-Sein (NCT00462696)
- Testing
- Neoadjuvant chemotherapy
- Where
- France
- Volunteers
- 16 people
- Sponsor
- Institut Bergonié
Cancer
Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain
This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain.
- Trial name
- NCT00538850
- Testing
- Fentanyl sublingual spray
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- INSYS Therapeutics Inc
Ductal Breast Carcinoma In Situ, Invasive Breast Carcinoma
Hypofractionated Radiation Therapy in Treating Patients With Stage 0-IIB Breast Cancer
This phase II trial studies how well hypofractionated radiation therapy works in treating patients with stage 0-IIB breast cancer.
- Conditions
- Ductal Breast Carcinoma In Situ, Invasive Breast Carcinoma, Stage 0 Breast Cancer, Stage I Breast Cancer
- Trial name
- NOVEMBER (NCT03345420)
- Testing
- Hypofractionated Radiation Therapy
- Where
- United States
- Volunteers
- 102 people
- Sponsor
- University of Utah
Breast Cancer
Radiation Therapy in Treating Women Who Have Undergone Surgery for Early-Stage Invasive Breast Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation to the tumor site and surrounding area may kill more tumor cells.
- Trial name
- NCT00005957
- Testing
- Standard Breast Irradiation, Breast Radiation plus Regional Radiation
- Where
- 26 sites in Canada
- Volunteers
- 1,832 people
- Sponsor
- NCIC Clinical Trials Group
Breast Cancer
External-Beam Partial-Breast Irradiation for Early Breast Cancer 40 Gy QD Over 2 Weeks
Standard therapy for patients with early stage breast cancer consists of surgery to remove the cancer followed by radiation therapy.
- Trial name
- NCT01581619
- Testing
- External Beam Partial-Breast Irradiation
- Where
- 4 sites in United States
- Volunteers
- 54 people
- Sponsor
- Massachusetts General Hospital
Triple-negative Breast Cancer
A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer
This is a global Phase III, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab (anti-programmed death-ligand 1 [anti-PD-L1] antibody) and…
- Trial name
- IMpassion031 (NCT03197935)
- Testing
- Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody, Nab-paclitaxel, Doxorubicin
- Where
- 68 sites in United States, Australia and 11 more
- Volunteers
- 333 people
- Sponsor
- Hoffmann-La Roche
Ductal Breast Carcinoma In Situ, Estrogen Receptor Positive
Accelerated Partial Breast Radiation Therapy Using High-Dose Rate Brachytherapy in Treating Patients With Early Stage Breast Cancer After Surgery
This phase II trial studies how well accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy works in treating patients with breast cancer that has not spread beyond the breast or the axillary lymph…
- Conditions
- Ductal Breast Carcinoma In Situ, Estrogen Receptor Positive, Invasive Breast Carcinoma, Progesterone Receptor Positive
- Trial name
- TRIUMPH-T (NCT02526498)
- Testing
- Accelerated Partial Breast Irradiation, High-Dose Rate Brachytherapy, Questionnaire Administration
- Where
- 10 sites in United States
- Volunteers
- 200 people
- Sponsor
- Rutgers, The State University of New Jersey
Ductal Breast Carcinoma In Situ, Estrogen Receptor Negative
Radiation Therapy in Treating Post-Menopausal Women With Early Stage Breast Cancer Undergoing Surgery
This phase II trial studies how well radiation therapy works in treating post-menopausal women with early stage breast cancer undergoing surgery. Radiation therapy uses high energy x rays to kill tumor cells.
- Conditions
- Ductal Breast Carcinoma In Situ, Estrogen Receptor Negative, Estrogen Receptor Positive, HER2/Neu Negative
- Trial name
- NCT01754519
- Testing
- Therapeutic Conventional Surgery, Radiation Therapy, Laboratory Biomarker Analysis
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Roswell Park Cancer Institute
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
Retinoid 9cUAB30 in Producing a Biologic Effect in Patients With Early Stage Breast Cancer
This phase 1b trial studies the biologic effect of 9cUAB30 on early stage breast cancer. 9cUAB30 is a retinoid X receptor (RXR)-selective retinoid that acts in a tissue selective manner with the goal of minimizing side effects, a…
- 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
- NCT02876640
- Testing
- Biospecimen Collection, Retinoid 9cUAB30, Therapeutic Conventional Surgery
- Where
- 5 sites in United States
- Volunteers
- 27 people
- Sponsor
- National Cancer Institute (NCI)
Ductal Breast Carcinoma in Situ, Invasive Ductal Breast Carcinoma
Caloric Restriction in Treating Patients With Stage 0-I Breast Cancer Undergoing Surgery and Radiation Therapy
This pilot clinical trial studies caloric restriction in patients with stage 0-I breast cancer during surgery and radiation therapy. Reducing caloric intake may prevent disease progression in patients with breast cancer.
- Conditions
- Ductal Breast Carcinoma in Situ, Invasive Ductal Breast Carcinoma, Invasive Lobular Breast Carcinoma, Lobular Breast Carcinoma in Situ
- Trial name
- CAREFOR (NCT01819233)
- Testing
- Behavioral dietary intervention, Therapeutic conventional surgery, Radiation therapy
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Breast Cancer
Radiation Therapy During Surgery in Treating Older Women With Invasive Breast Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation during surgery may be an effective treatment for breast cancer.
- Trial name
- NRR (NCT00182728)
- Testing
- surgery, therapy, radiation therapy
- Where
- United States
- Volunteers
- 89 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
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
Ductal Breast Cancer
Partial Breast Irradiation (PBI) for Selected Patients With Early Invasive or Non-Invasive Breast Cancer
The purpose of this study is to determine the feasibility of partial breast irradiation in participants with early invasive or non-invasive breast cancer.
- Trial name
- NCT00694577
- Testing
- Partial Breast Irradiation using 32 Gy / 8 fractions, Partial Breast Irradiation using 36 Gy / 9 fractions, Partial Breast Irradiation using 40 Gy /10 fractions
- Where
- 4 sites in United States
- Volunteers
- 324 people
- Sponsor
- Massachusetts General Hospital
Breast Cancer
A Study of Accelerated 3 Fraction Photon,Proton or Brachytherapy for Early Invasive and Noninvasive Breast Ca
This is an open label phase II study to determine the safety and efficacy of a novel 3 fraction daily dosing regimen for accelerated partial breast irradiation (APBI) for early invasive and noninvasive breast cancer.
- Trial name
- NCT02453737
- Testing
- Brachytherapy APBI, 3D-CRT (photon) APBI, Proton APBI
- Where
- 3 sites in United States
- Volunteers
- 170 people
- Sponsor
- Mayo Clinic
HER2-normal
Dose Dense Doxorubucin and Cyclophosphamide Followed by Eribulin Mesylate for the Adjuvant Treatment of Early Stage Breast Cancer
The purpose of this study is to assess the feasibility of dose-dense doxorubicin and cyclophosphamide followed by eribulin mesylate for adjuvant treatment of early stage breast cancer.
- Trial name
- NCT01328249
- Testing
- eribulin mesylate
- Where
- 2 sites in United States
- Volunteers
- 81 people
- Sponsor
- Eisai Inc.
Ductal Breast Carcinoma In Situ, Invasive Breast Carcinoma
Hypofractionated Radiation Therapy or Standard Radiation Therapy in Treating Patients With Ductal Breast Carcinoma In Situ or Early Invasive Breast Cancer
This randomized phase II trial studies how well hypofractionated radiation therapy (RT) works compared to standard RT in treating patients with ductal breast carcinoma in situ (DCIS) or early invasive breast cancer.
- Conditions
- Ductal Breast Carcinoma In Situ, Invasive Breast Carcinoma, Stage I Breast Cancer AJCC v6, Stage IA Breast Cancer AJCC v7
- Trial name
- NCT01266642
- Testing
- External Beam Radiation Therapy, Hypofractionated Radiation Therapy, Laboratory Biomarker Analysis
- Where
- 7 sites in United States
- Volunteers
- 301 people
- Sponsor
- M.D. Anderson Cancer Center
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
Neoadjuvant Study of Sequential Eribulin Followed by FAC Compared to Sequential Paclitaxel Followed by FEC in Early Stage Breast Cancer Not Overexpressing HER-2
The goal of this clinical research study is to learn if and how well eribulin, given in combination with standard chemotherapy, can treat early-stage breast cancer compared to paclitaxel given in combination with standard…
- Trial name
- NCT01593020
- Testing
- Paclitaxel, Eribulin, 5-Fluorouracil
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- M.D. Anderson Cancer Center
Breast Cancer, DCIS
CyberKnife Stereotactic Accelerated Partial Breast Irradiation (SAPBI)
This study will prospectively evaluate the technical feasibility, acute toxicity, late effects and oncologic outcomes of CyberKnife Stereotactic Accelerated Partial Breast Irradiation (CK-SAPBI) in early stage breast cancer.
- Conditions
- Breast Cancer, DCIS, Invasive Ductal Carcinoma
- Trial name
- CK-SAPBI (NCT02365714)
- Testing
- CK Stereotactic Accelerated Partial Breast Irradiation
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Georgetown University