Repeat Breast Conserving Surgery Followed by Daily Partial Breast Irradiation in Ipsilateral Breast

Breast Cancer Clinical Trial

Official title:

Repeat Breast Conserving Surgery Followed by Daily Partial Breast Irradiation for Participants With Ipsilateral Breast Tumor Recurrence Treated Initially With Breast Conserving Surgery and Whole Breast Radiation Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06129747
• Other study ID #: CASE4123
• Status: Recruiting
• Phase: Phase 2
• Start date: November 30, 2023
• Est. completion date: August 9, 2029

Study information

• Verified date: May 2024
• Source: Case Comprehensive Cancer Center
• Contact: Janice Lyons, MD
• Phone: (216) 844-2514
• Email: Janice.lyons[@]uhhospitals.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The standard treatment for participants whose cancer has returned after breast conserving surgery is radiation given twice daily (separated by at least 6 hours) for a total of 30 treatments. The purpose of this study is to find out if giving radiation once a day for 15 treatments after repeat breast conserving surgery works as well as giving it the standard way.

Description:

Breast cancer survival rates have greatly improved with advances in both screening and treatment. The standard of care for both early stage and selected locally advanced breast cancers is breast conserving therapy (BCT), consisting of a partial mastectomy followed by radiation treatment. Traditionally, a salvage mastectomy was the standard treatment for women who initially underwent BCT and experienced an ipsilateral breast tumor recurrence (IBTR). Many participants have become increasingly motivated to avoid mastectomy, and there has been rising interest in repeat BCS (Breast Conserving Surgery) with focal radiation for certain participants motivated to keep their breast. The current standard of care for breast re-irradiation after an in-breast tumor recurrence is partial breast irradiation consisting of a dose of 45 Gy delivered BID for 30 fractions. While this regimen demonstrated excellent local control and low AEs, the regimen itself is difficult for participants. Receiving RT twice daily at smaller doses per fraction (1.5 Gy) for 30 treatments can be burdensome, especially for those without reliable transportation or difficulty getting time away from work. Given the excellent local control rates and low rate of AEs, in this study, we hypothesize that daily hypofractionated EBRT(External Beam Radiation Therapy) for re-irradiation after repeat BCS would be at least as well tolerated with good local control and provide a more convenient option for participants than the current standard of care established by RTOG 1014. Some participants will present with high-risk features (e.g. age <50, high grade, ER negative tumors, close margins) making dose escalation an attractive option to improve local control. Options for dose escalation include sequential and concurrent administration of a boost.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: August 9, 2029
• Est. primary completion date: August 9, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Participants' recurrences must have histologically confirmed ductal carcinoma in-situ, invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies.

• Lesion size < 3 cm treated with a partial mastectomy. Participants with clinically and radiographically negative axillas do not require an axillary lymph node sampling unless they did not have prior axillary lymph node sampling (e.g. previous cancer was DCIS). Repeat sentinel lymph node biopsy is permitted.

• Unifocal breast cancer recurrence.

• Negative resection margins with at least a no tumor on ink from invasive and 2 mm margins for ductal carcinoma in-situ or a negative re-excision.

• Hormonal therapy is allowed. If chemotherapy is planned, the radiation is delivered first and chemotherapy must begin no earlier than two weeks following completion of radiation.

• Participants must be > 18 years of age. Because no dosing or adverse event data are currently available on the use of breast re-irradiation in participants =18 years of age, children are excluded from this study.

• Participants must have the ability to understand and the willingness to sign a written informed consent document.

• Performance status: ECOG Performance status = 2.

• Life expectancy of = 12months, in the opinion of and as documented by the investigator.

• Not based on gender; this trial is open to any gender, defined as self-representation of gender identity.

Exclusion Criteria:

• Participants with nodal or distant metastatic disease

• Participants with invasive lobular carcinoma, extensive lobular carcinoma in-situ, extensive ductal carcinoma in-situ (spanning more than 3 cm), or uncontrolled nonepithelial breast malignancies such as lymphoma or sarcoma.

• Participants with multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by at least 4 cm). Palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically or cytologically confirmed negative.

• Extensive intraductal component (EIC) by the Harvard definition, i.e. 1) more than 25% of the invasive tumor is DCIS and DCIS present in adjacent breast tissue. Presence of an EIC increases the chance of local recurrence, and as such, one might not be a candidate for repeat breast conservation.

• Participants with Paget's disease of the nipple.

• Participants with skin involvement.

• Participants with systemic lupus erythematosus requiring pharmacologic management, scleroderma, or dermatomyositis.

• Participants with psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent.

• Participants who are pregnant or lactating due to potential fetal exposure to radiation and unknown effects of radiation on lactating females.

• Participants with known BRCA 1/BRCA 2 mutations.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Radiation Therapy
Weeks 1, 2 and 3 Weeks 1, 2 and 3 will include 5 days of treatment. One radiation treatment to breast on each of the 5 days. Each radiation treatment session will last a 30 minutes.

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio
United States	University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-related adverse events as graded by CTCAE criteria	Rate of grade 3+ treatment-related skin, fibrosis, and breast pain adverse events occurring within 1 year from the completion of re-irradiation as graded by CTCAE criteria.	1 year from the completion of re-irradiation
Secondary	In-breast tumor recurrence rate	The overall in-breast tumor recurrence rate will be estimated using the cumulative incidence function.	3 years
Secondary	In-breast tumor recurrence rate	The overall in-breast tumor recurrence rate is estimated using the cumulative incidence function.	5 years
Secondary	In-breast tumor recurrence rate	The overall in-breast tumor recurrence rate will be estimated using the cumulative incidence function.	10 years
Secondary	Rate of freedom from mastectomy	The freedom from mastectomy rate will be estimated using the cumulative incidence function.	3 years
Secondary	Rate of freedom from mastectomy	The freedom from mastectomy rate will be estimated using the cumulative incidence function.	5 years
Secondary	Rate of freedom from mastectomy	The freedom from mastectomy rate will be estimated using the cumulative incidence function.	10 years
Secondary	Treatment-related adverse events	All treatment-related adverse events for the defined time periods	1 year from completion of re-irradiation
Secondary	Treatment-related adverse events	All treatment-related adverse events for the defined time periods	Overall for 3 years from completion of re-irradiation
Secondary	Evaluation of Cosmesis	Determined by an established Global Cosmesis Score grading from 1 through 4, with 1 being excellent and 4 being rated as poor	1 year
Secondary	Evaluation of Cosmesis	Determined by an established Global Cosmesis Score grading from 1 through 4, with 1 being excellent and 4 being rated as poor	3 years
Secondary	Overall survival rate	Overall survival will be estimated using Kaplan-Meier Method	3 years
Secondary	Overall survival rate	Overall survival will be estimated using Kaplan-Meier Method	5 years
Secondary	Overall survival rate	Overall survival will be estimated using Kaplan-Meier Method	10 years
Secondary	Mastectomy-free survival rate	Mastectomy-free survival will be estimated using Kaplan-Meier Method	3 years
Secondary	Mastectomy-free survival rate	Mastectomy-free survival will be estimated using Kaplan-Meier Method	5 years
Secondary	Mastectomy-free survival rate	Mastectomy-free survival will be estimated using Kaplan-Meier Method	10 years