De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)

Conditions

• Stage I Breast Cancer

Eligibility Criteria

Sex

ALL

Age

50 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Radiation and Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane) — OTHER
  Post lumpectomy radiation therapy will be external beam radiation to either the whole breast + boost, partial breast irradiation, or Accelerated Partial Breast Irradiation that must begin within 12 weeks of the last breast cancer surgery(including re-excision of margins). Endocrine therapy for a minimum of 5 years. The specific regimen of endocrine therapy is at the treating physician's discretion. The dose and schedule of the drug(s) used for endocrine therapy should be consistent with the instructions in the drug package insert(s). Endocrine therapy may be initiated before, during, or after completion of radiation therapy at the discretion of the investigator.
• Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane) — DRUG
  Endocrine therapy for a minimum of 5 years. The specific regimen of endocrine therapy is at the treating physician's discretion. The dose and schedule of the drug(s) used for endocrine therapy should be consistent with the instructions in the drug package insert(s).

Study Details

This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy.

Key Dates

Start date

Jun 23, 2021

Status verified

Apr 2026

Primary completion

Apr 8, 2031

Completion

Jul 31, 2041

Study Design

Enrollment

1,670 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm 1: Breast Radiation Therapy + Endocrine Therapy
  Radiation therapy to the breast and hormonal drug for at least 5 years. Tamoxifen 20 mg daily Anastrozole 1 mg daily Letrozole 2.5 mg daily Exemestane 25 mg daily
• Active Comparator: Arm 2: No Breast Radiation Therapy + Endocrine Therapy
  No radiation therapy, only hormonal drug for at least 5 years. Tamoxifen 20 mg daily Anastrozole 1 mg daily Letrozole 2.5 mg daily Exemestane 25 mg daily

Primary Outcome Measure

Time to invasive or noninvasive IBTR. [ Time Frame: 5 years ]

Central Contacts

• Director Department of Regulatory Affairs
  412-339-5300
  [email protected]
• Norman Wolmark, MD

Locations (812)