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

NCT06129747 | Recruiting Phase 2 DMC

• 1 other identifier: CASE4123
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Breast Cancer; Tumor, Breast

Keywords

Radiation Therapy; In-Breast Recurrence; Tumor; Re-irradiation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• In-breast tumor recurrence rate

  3 years

• In-breast tumor recurrence rate

  5 years

• In-breast tumor recurrence rate

  10 years

• Rate of freedom from mastectomy

  3 years

• Rate of freedom from mastectomy

  5 years

Study Arms (1)

Radiation Therapy(RT)

EXPERIMENTAL

There will be one treatment cohort. Radiation therapy will be delivered daily for 15 daily fractions, 2.67Gy per fraction, delivered using a 3-D or IMRT(Intensity Modulate Radiation Therapy) plan. For participants with high-risk features deemed by the radiation oncologist who would otherwise be a candidate for a boost (age \<50, high grade, poor biology, close margins), 48 Gy delivered in fifteen fractions of 3.2 Gy is allowed.

Radiation: Radiation Therapy

Interventions

Radiation Therapy RADIATION

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.

Radiation Therapy(RT)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants' recurrences must have histologically confirmed ductal carcinoma in-situ, invasive ductal, medullary, papillary, colloid (mucinous), tubular or mixed histologies. Three years of time must have elapsed since the end of the last course of whole breast irradiation.
• Lesion size \< 3 cm treated with a partial mastectomy. Participants with invasive cancer and 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). Participants with DCIS as their recurrence do not require surgical assessment of the axilla. Repeat sentinel lymph node biopsy is permitted.
• Negative resection margins with at least no tumor on ink or a negative re-excision.
• Participants with invasive recurrence must have a negative re-staging work-up consisting of either a CT chest/abdomen and a bone scan or a PET scan.
• Hormonal therapy is allowed. If chemotherapy is planned, it can be delivered either prior to or after the radiation is delivered. There must be at least 2 weeks between radiation and chemotherapy. HER2 directed therapy can be delivered concurrently with 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.

You may not qualify if:

• Participants with nodal or distant metastatic disease \< 3 years since prior radiation.
• Participants with invasive pure 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.
• Participants with Paget's disease of the nipple.
• Participants with skin involvement.
• Participants with 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (2)

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

RECRUITING

Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Janice Lyons, MD

  University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

• Rahul Tendulkar, MD

  Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janice Lyons, MD

CONTACT

(216) 844-2514; Janice.lyons@uhhospitals.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will receive once daily radiation for 15 fractions to 40.05 Gy total dose. Participants with high risk features (high grade disease, young age, close margins (\<2mm), triple negative subtype, HER2 positive tumors not receiving HER2 targeted systemic therapy) may receive a simultaneous boost to 48 Gy in 15 fractions.

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 13, 2023
• Study Start: November 30, 2023
• Primary Completion (Estimated): August 9, 2029
• Study Completion (Estimated): August 9, 2029
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)