Purpose

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

IRB Number
20170532HU
NCT Number
NCT01928589
Open to Enrollment
Yes
Sponsor
Richard Zellars -



Study Contact

Patricia Devore
(210) 450-1233
devore@uthscsa.edu

Principal Investigator
Mark Bonnen

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



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

    ents who have received neoadjuvant chemotherapy or neoadjuvant hormonal therapy for the current cancer. Patients with squamous or sarcomas of the breast. Patients who have active local-regional disease prior to registration. Patient has other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in sity cervical cancer, or any other cancer from which the patient has been disease-free for less than 5 years.

    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

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Randomized trial of PBI with concurrent or sequential chemotherapy
Primary Purpose
Treatment
Masking
None (Open Label)
Condition
  • Breast Cancer
  • Adenocarcinoma of the Breast

    • Arm Groups

    ArmDescriptionIntervention
    Experimental

    PBI with chemotherapy

    		270 cGy (centigray) x 15 concurrent with chemotherapy of the treating medical oncologist's choice
  • Other: PBI with concurrent chemotherapy

    270 cGy x15 concurrent with chemotherapy of the treating medical oncologist's choice

    Other names:

    • partial breast irradiation with chemotherapy

    • Active Comparator

    PBI

    		270 cGy (centigray) x 15
  • Other: PBI with concurrent chemotherapy

    270 cGy x15 concurrent with chemotherapy of the treating medical oncologist's choice

    Other names:

    • partial breast irradiation with chemotherapy

  • Radiation: PBI with sequential chemotherapy

    270 cGy x15

    Other names:

    • partial breast irradiation with sequential chemotherapy

    •