Study of a Shortened Radiation Therapy Schedule in People With Breast Cancer

NCT04648904 | Active Not Recruiting Early Phase 1

• 1 other identifier: 20-513
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see whether providing radiation on a shortened (compressed) schedule of 5 days in a row is a safe and effective approach to prevent cancer from coming back in people who have had a mastectomy.

Conditions

Invasive Breast Cancer; Post-mastectomy

Keywords

AJCC Stage IIa - IIIa; Pathologic stage T0N1a-2a; Pathologic stage T1N1a-2a; Pathologic stage T2N1a-2a; Pathologic stage T3N0-2a, all M0 status; Radiotherapy; Ultra-compressed Treatment; 20-513; T3N0 patients

Outcome Measures

Primary Outcomes (2)

• Local recurrences

  Local recurrence is defined as histologic evidence of ductal carcinoma in situ or invasive breast cancer in the ipsilateral reconstructed breast or chest wall.

  3 years

• Regional recurrences

  Regional recurrence is defined as the cytologic, histologic and/or radiographic evidence of disease in the ipsilateral internal mammary, ipsilateral supraclavicular, ipsilateral infraclavicular and/or ipsilateral axillary nodes or soft tissue of the ipsilateral axilla.

  3 years

Secondary Outcomes (1)

• complications

  3 years

Study Arms (1)

Post-Mastectomy Radiotherapy

EXPERIMENTAL

Treatment will consist of PMRT delivered using external beam RT techniques to a dose of 26 Gy in 5 fractions of 5.2 Gy delivered on consecutive weekdays with an optional chest wall boost of 5.2 Gy for 1-2 fractions or an alternate boost schedule of 2.5 Gy for 1-4 fractions at the discretion of the treating physician.

Radiation: Radiotherapy

Interventions

Radiotherapy RADIATION

A total dose of 26 Gy in 5 fractions will be given once daily over 5 consecutive weekdays (or within 10 consecutive weekday to allow for treatment delays, interruptions, logistical problems, scheduling issues and weekends/holidays).

Post-Mastectomy Radiotherapy

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male patients with invasive breast cancer who have had mastectomy and have a chest wall reconstruction in progress or completed.
• Age ≥ 30 years
• Final AJCC Stage IIa - IIIa (pathologic stage T0N1a-2a, T1N1a-2a, T2N1a-2a, T3N0-2a, all M0 status). Pathological stage for all patients not receiving neoadjuvant chemotherapy. Higher of the clinical or pathological T and N stage, if receiving neoadjuvant chemotherapy. T3N0 patients, either clinically by imaging before neoadjuvant chemotherapy, or by pathological stage at the time of surgery, are eligible. Exceptions to these criteria (e.g. for T4 or N3 patients) are possible after discussion with PI.
• Histologically negative tumor margin.
• ECOG Performance Status of 0 or 1

You may not qualify if:

• Patients with distant metastasis.
• Patients who are pregnant or breastfeeding.
• Prior radiation therapy to the ipsilateral or contralateral breast or thorax.
• All patients with clinical, radiographic or pathological T4, N3 or involved internal mammary disease (N1b, N1c, and N2b) will not be eligible to enroll.
• Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus, or connective tissue diseases (lupus, systemic sclerosis, or other collagen vascular diseases) that, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.
• Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have "currently active" malignancies if they have completed therapy and are considered by their physicians to be at \<5% risk of relapse within 3 years.
• Concomitant anti-neoplastic treatment is not allowed during protocol treatment and should be completed at least 2 weeks prior to commencement of protocol treatment, with resolution of associated acute toxicities. However endocrine therapies (tamoxifen or aromatase inhibitors), anti-HER2 therapy and bisphosphonates are permitted without restriction even during protocol treatment. Standard-of-care maintenance treatments such as pembrolizumab and capecitabine are permitted during protocol treatment. All of these treatments are delivered routinely as SOC during conventional radiotherapy.
• Unwilling or unable to participate in all required study evaluations and procedures. Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local patient privacy regulations).

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Aftif Khan, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-arm, single-site, prospective non-inferiority trial of PMRT delivered in the compressed FAST FORWARD schedule.

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 2, 2020
• Study Start: November 24, 2020
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)