Radiation Therapy and Sequential or Concurrent Combination Chemotherapy in Treating Patients with Early Stage Breast Cancer

Status: Active

Description

This randomized phase II trial studies how well radiation therapy and sequential or concurrent combination chemotherapy works in treating patients with early stage breast cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab is a form of “targeted therapy” because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the body’s immune system. It is not yet known whether radiation therapy is more effective with sequential or concurrent combination chemotherapy in treating early stage breast cancer.

Eligibility Criteria

Inclusion Criteria

  • Patient must have histologically confirmed (by routine hematoxylin and eosin [H&E] staining) invasive adenocarcinoma of the breast
  • Primary tumor =< 4 cm 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 and trastuzumab (TCH) prior to registration; 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 principal investigator (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
  • Eastern Cooperative Oncology Group (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 child-bearing potential must also use effective non-hormonal contraception while undergoing radiation therapy
  • 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 malignancy from which the patient has been disease-free for less than 5 years; notable exceptions to this are adequately treated squamous or basal cell cancer of the skin and in-situ cervical cancer
  • Patient is pregnant
  • Patient has a serious medical or psychiatric illness which prevents informed consent or adherence with treatment
  • Study team (PI, co-investigator [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

Locations & Contacts

District of Columbia

Washington
Sibley Memorial Hospital
Status: Active
Contact: Victoria Jane Croog
Phone: 202-537-4788
Email: vcroog1@jhmi.edu

Indiana

Fort Wayne
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Status: Active
Contact: Christine Spillson
Phone: 260-266-5600
Email: christine.spillson@parkview.com
Parkview Regional Medical Center
Status: Active
Contact: Karen Ann Kreiger
Phone: 260-266-6622
Email: karen.kreiger@parkview.com
Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: Active
Contact: Richard C. Zellars
Phone: 317-948-9348
Email: rzellars@iu.edu
Lafayette
IU Health Arnett Cancer Care
Status: Active
Contact: Samuel Durham
Phone: 765-838-6885
Email: sdurham1@iuhealth.org

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Contact: Jean Lundberg Wright
Phone: 305-588-4511
Email: jeanwright@jhmi.edu
Bethesda
Suburban Hospital
Status: Active
Contact: Susan Fletcher Stinson
Phone: 301-896-2012
Email: Bsquiller@suburbanhospital.org

Pennsylvania

York
WellSpan Health-York Cancer Center
Status: Active
Contact: Amit B. Shah
Phone: 877-441-7957
Email: ashah@wellspan.org

Texas

San Antonio
University of Texas Health Science Center at San Antonio
Status: Active
Contact: Carol A. Jenkins
Email: jenkinsca@uthscsa.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. Non-inferiority of partial breast irradiation (PBI) and concurrent compared to sequential chemotherapy with respect to acute grade 3-4 radiation toxicity.

SECONDARY OBJECTIVES:

I. Evaluate and compare any first tumor recurrence (local plus distant) between arms of the study.

II. Evaluate long term toxicity with concurrent chemotherapy and compare between arms of the study.

III. Evaluate and compare ipsilateral breast tumor reocurrence (IBTR), local recurrence, distant recurrence, and disease free survival.

IV. Give a description of the risks and benefits observed in each arm of the study over the duration of the trial.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo external beam radiation therapy (EBRT) on weekdays for a total of 15 fractions. After completion of EBRT, patients receive cyclophosphamide and doxorubicin hydrochloride; docetaxel, cyclophosphamide and doxorubicin hydrochloride; docetaxel and cyclophosphamide; or docetaxel, carboplatin, and trastuzumab at the discretion of the treating Medical Oncologist.

ARM II: Patients undergo EBRT as in Arm I. Within 7 days of the start of radiation therapy, patients also receive combination chemotherapy as in Arm I.

After completion of study treatment, patients are followed up at 1-2 weeks, 3-4 months, 6-7 months, every 6 months for years 1-3, every 6-12 months for years 3-5, and then annually for years 5-10.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Indiana University / Melvin and Bren Simon Cancer Center

Principal Investigator
Richard C. Zellars

Trial IDs

Primary ID J13104
Secondary IDs NCI-2013-02402, CRMS-57980, NA_00086037, J-13104, CIR00000810
Clinicaltrials.gov ID NCT01928589