Preoperative Irradiation for Stage I Breast Cancer: A Phase IB Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Parul Barry
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Maximum tolerated dose (MTD)
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
The novel use of preoperative RT will have broad implications for breast cancer patients, most of whom present with early-stage disease. In the era of reduced chemotherapy delivery, preoperative RT will allow oncologists to assess radiologic and biologic tumor response and correlate it to outcomes. Underutilization of RT negatively affects mortality. This trial aims to further evaluate pre-operative radiation therapy in patients with early stage, biologically favorable breast cancer, with improved access to RT.
Detailed Description
This trial is a dose escalation study where we will evaluate preoperative dose-escalated RT in four cohorts and determine the maximum tolerated dose (MTD)In the first cohort, patients will be assigned to receive the standard dose of 30 Gy in 5 fractions to the planning target volume (PTV) and 30 GY in 5 fractions to the gross target volume (GTV). In the subsequent cohorts patients will receive 30 Gy in 5 fractions to the PTV with dose-escalation of the GTV to 35 Gy, 40 Gy, and 50 Gy respectively. An interim analysis will be performed after 40 Gy to assess toxicity.
Investigators
Parul Barry
Clinical Assistant Professor, Radiation Oncology
University of Pittsburgh
Eligibility Criteria
Inclusion Criteria
- •Pathologically confirmed diagnosis of breast cancer within 90 days from breast biopsy. NOTE: The day of biopsy is Day "0"
- •Patient biologically of the female sex
- •Must meet ALL the following criteria:
- •Age ≥ 50 years
- •Clinical size ≤ 3 cm (invasive) or ≤ 4 cm (DCIS) based on results of dedicated breast imaging.
- •All invasive subtypes and DCIS
- •ER positive, HER2/neu negative
- •Clinically negative lymph nodes based on results of dedicated breast imaging
- •The gross tumor should be \>1cm from the chest wall and the skin surface
- •Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2 within 90 days prior to registration
Exclusion Criteria
- •Clinically staged breast cancer that does not meet all of the criteria delineated in Inclusion criteria
- •Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 5 years prior to study entry
- •Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix, melanoma in situ) unless disease free for a minimum of 5 years prior to study entry
- •Non-epithelial breast malignancies such as sarcoma or lymphoma.
- •Two or more documented breast cancers within the index breast or bilateral breast cancer.
- •Suspicious unresected microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.
- •Paget's disease of the nipple.
- •Male breast cancer.
- •Evidence of distant metastases.
- •Clinical regional lymph node involvement.
Outcomes
Primary Outcomes
Maximum tolerated dose (MTD)
Time Frame: Up to18 months (cohort)
Maximum tolerated dose (MTD) of RT, which will be defined based on the occurrence of grade 2 or higher acute radiation dermatitis as defined per National Cancer Institute, Common Terminology Criteria for Adverse Events (CTCAE) v5.0, occurring within approximately 1 month after radiation therapy (RT). Dose escalation will begin with 30 GY and be escalated to 35, 40, and 50 GY as tolerated.
Secondary Outcomes
- Acute Toxicities(Up to 1 month)
- Late toxicities(From 6 months, up to 24 months)
- Pathologic Complete Response (pCR)(Up to 3 years)
- Quality of Life - EORTC QLQ BR23(At baseline (prior to RT), at 1 month, 6 months, 1 year, 2 years, and 3 years after RT)
- Breast Cancer Treatment Outcome Scale (BCTOS)(At baseline (prior to RT), at 1 month, 6 months, 1 year, 2 years, and 3 years after RT)
- Loco-regional recurrence(Up to 5 years)
- Disease free Survival (DFS)(Up to 5 years)
- Overall survival (OS)(Up to 5 years)
- Cosmesis (cosmetic outcome)(At baseline (prior to RT), up to 3 years after RT)