Partial Irradiation and Sequential vs. Concurrent Chemo Early Breast Cancer
Lay Description
In a small study at Johns Hopkins, women were treated with partial breast irradiation and chemotherapy given at the same time.
We are now testing in a bigger study whether giving partial breast irradiation and chemotherapy at the same time (our new method) has the same side effects and outcomes as giving partial breast irradiation and chemotherapy at different times(older method). In this study women who had their breast cancer removed but need radiation to the breast will be randomized to partial breast irradiation at the same time as chemotherapy or partial breast radiation at a different time than chemotherapy. Randomization is like flipping a coin but in this study about 2 of every 3 women will get the new method.
Category
- Cancers and Other Neoplasms
- Womens Health
- Breast
- IRB Number
- 20170532HU
- NCT Number
- NCT01928589
- Open to Enrollment
- Yes
Eligibility
- Eligible Ages
- Between 18 Years and 100 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
≥ 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. Ability to understand and the willingness to sign a written informed consent document.
<Exclusion Criteria
Patient is pregnant. Patient has a serious medical or physciatric 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.
Study Design
Arm Groups
Study Contact
Mark Bonnen
(210) 450-1719
bonnen@uthscsa.edu
Frances Crawford
(210) 450-5037
crawfordf1@uthscsa.edu
Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu
Patricia Devore
(210) 450-1233
devore@uthscsa.edu
Mohamad Fakhreddine
(210) 450-5652
fakhreddine@uthscsa.edu
Myrna Montenegro
(210) 450-5954
montenegro@uthscsa.edu
Courtney Nichols
(210) 450-1794
nicholsc2@uthscsa.edu
Mailbox Ctrc Regulatory Affairs
regaffapp@uthscsa.edu
Regulatory Staff
regaffstaff@uthscsa.edu
Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu
Benjamin Schleif
(210) 450-1366
schleifb@uthscsa.edu
Morgan Seekatz
(210) 450-1133
seekatz@uthscsa.edu
Patricia Devore
(210) 450-1233
devore@uthscsa.edu
Principal Investigator
Mark Bonnen