Partial Irradiation and Sequential vs. Concurrent Chemo Early Breast Cancer
Breast Cancer, Adenocarcinoma of the Breast
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Cyclophosphamide, Doxorubicin, Docetaxel, Carboplatin, Herceptin, Partial Breast Irradiation, Concurrent Chemotherapy
Eligibility Criteria
Inclusion Criteria Age ≥ 18 years. Patient must have histologically confirmed (by routine H&E staining) invasive adenocarcinoma of the breast. Primary tumor ≤ 4cm and 0-3 positive axillary lymph nodes (T1-2, N0-1, M0). Margin negative surgery. For subjects with two breasts, they must have had a bilateral mammogram prior to surgery. Patient must have a Medical Oncology consult with the recommendation of chemotherapy. Recommended regimens are as follows: Cyclophosphamide and Doxorubicin (AC); Taxotere, Doxorubicin and Cyclophosphamide (TAC); Taxotere and Cyclophosphamide (TC); or Taxotere, Carboplatin withTrastuzamab (TCH) prior to registration; or Paclitaxel and Trastuzumab. The use of additional chemotherapy, hormonal therapy or Trastuzumab after the initial regimen is at the discretion of the Medical Oncologist. Other primary regimens are possible but the PI must be notified prior to enrollment. Partial breast irradiation must be scheduled to begin less than 71 days from the last breast surgical procedure. ECOG performance status ≤ 1. Women of child-bearing potential must have a negative (urine or blood) pregnancy test within 6 weeks prior to start of protocol therapy. Women of childbearing potential must also use effective non-hormonal contraception while undergoing radiation treatment and chemotherapy. Note: Women over the age of 70 will not be considered as having child-bearing potential for this study.
Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria Patients who have received neoadjuvant chemotherapy or neoadjuvant hormonal therapy for the current cancer. Patients with squamous cell cancer or sarcomas of the breast. Patients who have active local-regional disease prior to registration. Patient with a prior ipsilateral breast cancer (invasive or non-invasive) from which the patient has been disease free for less than 5 years.
Patient has a serious medical or psychiatric illness which prevents informed consent or adherence with treatment. Study team (PI, Co-I, and or research nurse) may deny enrollment if in the study team's opinion, the candidate may not be adherent to the treatment protocol including scheduled follow-ups.
Sites / Locations
- Sibley Memorial Hospital
- Parkview Regional Medical Center
- Indiana University Health Hospital
- Indiana University Health Melvin and Bren Simon Comprehensive Cancer Center
- IU Health Arnett
- John Hopkins University
- Suburban Hospital
- Reading Hospital
- York Cancer Center
- University of Texas-San Antonio
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
PBI
PBI with chemotherapy
270 cGy (centigray) x 15
270 cGy (centigray) x 15 concurrent with chemotherapy of the treating medical oncologist's choice