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Breast: Post-Mastectomy: Hypofractionated Radiotherapy: RT CHARM

RT CHARM: Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation With Breast Reconstruction

Title

Alliance: A221505 \\\"RT Charm\\\"

Study Title

RT CHARM: Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation With Breast Reconstruction

Site Link

NCT03414970

Malignancy

Breast cancer

Stage

Stage 2

Disease Setting

Adjuvant: Curative

Line Of Therapy

Adjuvant

Investigational Agent

Hypofractionated radiotherapy

Drug Class

Radiation

Noam VanderWalde, MD

Sponsor

Alliance for Clinical Trials in Oncology

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

Key Eligibility Criteria Details

Invasive breast cancer (ductal, lobular, tubular, mammary, medullary)
If received neoadjuvant therapy, pre treatment staging must have N1 or N2 disease pre-chemo or are T3N0
If did not receive neoadjuvant, must be T0N1-2a, T1N1-2a, T2N1-2a, or T3N0-2a.
No prior therapeutic radiation to the chest, neck, or axilla
No prior history of ipsilateral breast cancer
- DCIS or LCIS are allowed
Negative margins following mastectomy
No significant post mastectomy complications in the ipsilateral breast requiring unplanned re-operation or admission for IV antibiotics.
- Reoperation for margins or lymph node dissection is allowed
Radiation oncologist is NOT planning to use a chest wall/scar boost
Radiation oncologist is planning to treat regional lymph nodes including internal mammary nodes and meet acceptable protocol dosimetric requirements
No co-existing medical conditions with a life expectancy <5 years
ECOG PS 0-1

Objective

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Invasive ductal, invasive lobular, tubular

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes