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

Invasive Breast Cancer Clinical Trial

Official title:

Fractionation Accelerated Beyond Standard Therapy for Post-Mastectomy Radiotherapy in Patients With Reconstructions (FAST-R Trial): A Prospective Non-inferiority Trial of Ultra-compressed Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04648904
• Other study ID #: 20-513
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 24, 2020
• Est. completion date: November 2024

Study information

• Verified date: February 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Aftif Khan, MD
• Phone: 848-225-6334
• Email: khana7[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Breast Neoplasms
• Invasive Breast Cancer
• Post-mastectomy

Intervention

Radiation:
• Radiotherapy
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).

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	complications	CTCAE toxicities: will evaluate the incidence of any reported acute and late radiotherapy complications using the CTCAE 5.0 grading system when possible.	3 years

External Links

•   Memorial Sloan Kettering Cancer Center