Clinical trial NCT04648904: Study of a Shortened Radiation Therapy Schedule in People With Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
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
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2020-12-02
Enrollment: 71
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-arm, single-site, prospective non-inferiority trial of PMRT delivered in the compressed FAST FORWARD schedule.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Local recurrences
timeFrame: 3 years
measure: Regional recurrences
timeFrame: 3 years
Secondary outcomes:
measure: complications
timeFrame: 3 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Aftif Khan, MD
role: PRINCIPAL_INVESTIGATOR
References: