Ultrahypofractionated Whole Breast Radiation Following Chemotherapy

NCT06664892 | Not Yet Recruiting DMC

• 1 other identifier: MHCI 24-01
• Study Type: interventional
• Target: 213
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single institution, non-randomized, non-inferiority study comparing prospectively collected data for acute and late effects on the breast associated with ultrahypofractionated whole breast radiation (WBI) following breast conserving surgery (BCS) and chemotherapy to historical controls for breast cancer (BC) patients who receive hypofractionated RT following BCS and chemotherapy.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Primary(1)

  Incidence of acute toxicities during and up to 3 months following completion of RT in BC patients who receive ultrahypofractionated WBI in BC patients who have received prior chemotherapy compared to historic controls for BC patients who have received prior chemotherapy and hypofractionated RT

  up to 3 months

• Primary (2)

  Incidence of late toxicities of the breast up to 2 years following completion of RT in BC patients who receive ultrahypofractionated WBI in BC patients who have received prior chemotherapy compared to historic controls for BC patients who have received prior chemotherapy and hypofractionated RT

  Up to 2 years

Secondary Outcomes (2)

• Secondary (1)

  Up to 3 months

• Secondary (2)

  Up to 2 years

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Radiation: Ultra-hypofractionated radiation

Interventions

Ultra-hypofractionated radiation RADIATION

RT, delivered via external beam, 5.2 Gy per fraction for 5 fractions following BCS and neoadjuvant or adjuvant chemotherapy. Specific adjuvant/neoadjuvant therapies are at the discretion of the treating Medical Oncologist.

Treatment Arm

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged at least 60 years with invasive BC (T1-3) with clinically or pathologically negative axillary nodes following BCS who have a high-risk Mammaprint or Oncotype testing and receive chemotherapy. (If no axillary surgery planned, patients must have pre-operative negative axillary ultrasound)
• Invasive ductal, lobular, medullary, papillary, colloid (mucinous), or tubular histologies are allowed
• Any receptor status is allowed (ER/PR/Her2-neu)
• Patients with negative resection margins defined as 2 mm from ink, or a negative re-excision
• Nodal RT is not allowed
• There must be no concern for distant metastatic disease
• Patients must be deemed fit to receive the prescribed systemic therapy
• Immunotherapy is allowed
• Targeted Her-2 neu therapy, including concurrent therapy is allowed
• Other targeted therapies are allowed (including but not limited to CDK inhibitors)
• Endocrine therapy, including concurrent therapy is allowed
• Participation in other non-RT clinical trial is allowed
• Must be able to sign informed consent

You may not qualify if:

• Patients with stage IV BC
• Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re-excision, the patient is eligible)
• Prior thoracic or breast RT
• The following RT methods and techniques are not permitted:
• Brachytherapy or intraoperative RT (IORT)
• Proton therapy
• Regional nodal RT
• Tumor bed boost
• Patients who have breast reconstruction with implant or expander
• Patients who have had a mastectomy for current BC
• Patients requiring a tumor bed boost
• Palpable or radiographic suspicious or contralateral lymph nodes or N2 disease
• Paget's disease of the nipple.
• Non-epithelial breast malignancies such as sarcoma or lymphoma
• History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to study entry

Sponsors & Collaborators

• MetroHealth Medical Center: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Suzanne Russo, MD

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Koretia Williams, MBA

CONTACT

216-778-5470; kwilliams7@metrohealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 30, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 14, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share