Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

6 TEC q 3 weeks

4 EC q 2 weeks followed by 4 TXT q 2 weeks

4 TXT q 2 weeks followed by 4 EC q 2 weeks

Pascal Piedbois, MD, PhD

To screen a dose-dense arm to be used in a future large scale phase III trial. Primary endpoint is safety; secondary endpoints are disease free survival and overall survival. A total of 100 patients were included.

Randomized Phase II Trial of Dose Dense Docetaxel in N+ Breast Cancer

A Phase II Randomized Trial of 6 TEC Every 3 Weeks, Versus 4 EC Followed by 4 Taxotere Every 2 Weeks, Versus 4 Taxotere Followed by 4 EC Every 2 Weeks in Node Positive Breast Cancer

Aventis Pharmaceuticals

Amgen

Association Européenne de Recherche en Oncologie

Antioxidants

This study will investigate the null hypothesis that use of antioxidant supplements during adjuvant chemotherapy will have no impact on toxicities and disease-free, as well as overall, survival, and also evaluate the role of polymorphisms in genes related to oxidative stress in relation to treatment outcomes.

This study will enroll 3000 women from S0221with node positive or high-risk node-negative breast cancer receiving AC+T onto this ancillary study to address the following specific aims:

1. To characterize use of antioxidant supplements with a survey instrument prior to and at completion of treatment, and to evaluate reported use pre and post treatment in relation to toxicity and disease-free survival. The potential effects of diet, physical activity, and other lifestyle factors on relationships between supplement use and treatment outcomes will also be considered.
2. To evaluate if variants (polymorphisms) in genes that produce reactive oxygen species (ROS) (MPO) and in genes that protect cells from the effects of ROS are associated with treatment-related toxicities and with disease-free survival.

Antioxidant Supplements, Genetics and Chemotherapy Outcomes

Self administered questionnaire to evaluate use of antioxidant supplements in relation to toxicity

Polymorphisms will be determined by sequencing as described in detail on the National Cancer Institute'sSNP500Cancer database

Self administered questionnaire to evaluate use of antioxidant supplements in relation to disease free survival

Roswell Park Cancer Institute

Risk groups based on dosimetric radiation parameters.

Radiation Therapy treatment between 2000 and 2007.

Radiation therapy groups

Carmen R Bergom, MD, PhD

The association between radiation exposure and cardiac disease is well recognized, it is not fully understood if there exists an optimal or "safe" radiation dose-volume relationship.

Identification of "safe" dose volume constraints (DVC) for the heart from breast cancer radiotherapy would permit maximal oncologic benefit from radiation, identifying which patients require more complicated and resource consumptive radiation methods such as respiratory-gating or intensity modulated radiotherapy (IMRT) and establish patients who need targeted follow-up for their long term cardiac risk. Two recent technical developments now make it conceivable to identify the dose-volume relationship between heart dose and subsequent cardiac event risk: 1. CT based three dimensional conformal radiation delivery methods (3DCRT) where the precise radiation dose to any given heart volume is known, and 2. Cardiac MRI (CMR) that is more sensitive to prior methods of cardiac evaluation (e.g. SPECT) for detecting and measuring cardiac injury.

An MRI, subject health questionnaire, clinical and dosimetric data will be included in the analysis.

Evaluate Cardiac Function Using Cardiac MRI and Dosimetric Correlation

Pilot Study to Evaluate Cardiac Function Using Cardiac MRI and Dosimetric Correlation in Women Treated for Node Positive Breast Cancer With Three- Dimensional Conformal Radiation Therapy (3DCRT)

Data available upon request after publication of findings.

Trial data will improve the understanding of cardiac function after radiotherapy and allow oncologists to start to define safe dose-volume constraints for the heart in women treated with regional nodal irradiation for breast cancer.

Cardiac MRI parameters include Left Ventricular (LV) ejection fraction, LV mass (indexed), LV dimensions, extracellular volume (ECV), and late gadolinium enhancement (LGE).

Correlate cardiac MRI parameters with pre-treatment heart imaging and cardiac dose volume constraints as a measure of cardiac injury after partial heart irradiation in women with node positive breast cancer treated with surgery, anthracycline-based chemotherapy and regional nodal irradiation.

Medical College of Wisconsin

Associate Professor

Risk groups based on dosimetric radiation parameters and eligibility criteria.

Radiation therapy groups: Radiation Therapy treatment between 2000 and 2009.

Radiation Therapy Groups

Risk groups based on dosimetric radiation parameters.

Radiation therapy groups: Radiation Therapy treatment between 2000 and 2007.

Age, Categorical

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

Dr. Carmen Bergom

LVEF, more than 1% outside normal range

LV mass (indexed), higher than normal

LV chamber dimensions, higher than normal

Total Myocardial ECV, above 30%

Cardiac MRI Parameters

Correlate Cardiac MRI Parameters

Dose-volume Constraints for the Heart During Radiation Therapy for Breast Cancer.

Risk groups based on dosimetric radiation parameters and eligibility criteria.

Radiation therapy groups: 3D Conformal Radiation Therapy (3DCRT) to breast/chestwall and regional lymph nodes with treatment between 2000 and 2009.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Randomized Phase II Trial of Dose Dense Docetaxel in N+ Breast Cancer	NCT00189670	Node Positive B...	6 TEC q 3 weeks 4 EC q 2 weeks ... 4 TXT q 2 weeks...	18 Years -	Association Européenne de Recherche en Oncologie
Antioxidant Supplements, Genetics and Chemotherapy Outcomes	NCT03413761	Node Positive B... Node Negative B...		18 Years -	Roswell Park Cancer Institute
Antioxidant Supplements, Genetics and Chemotherapy Outcomes	NCT03413761	Node Positive B... Node Negative B...		18 Years -	Roswell Park Cancer Institute
Randomized Phase II Trial of Dose Dense Docetaxel in N+ Breast Cancer	NCT00189670	Node Positive B...	6 TEC q 3 weeks 4 EC q 2 weeks ... 4 TXT q 2 weeks...	18 Years -	Association Européenne de Recherche en Oncologie
Evaluate Cardiac Function Using Cardiac MRI and Dosimetric Correlation	NCT02348684	Node Positive B...	Radiation thera...	18 Years - 95 Years	Medical College of Wisconsin

Spots Global Cancer Trial Database for node positive breast cancer