Boosting radiation treatment for high-risk breast cancer patients

Evaluating the Efficacy and Safety of Boost Irradiation to the Supraclavicular Area Among High Risk cN3c Breast Cancer Patients According to Nodal Response: a Single-arm, Prospective Clinical Study

This study is testing if adding extra radiation treatment to a specific area can help high-risk breast cancer patients live longer after their initial therapy.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Ruijin Hospital (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06404697 on ClinicalTrials.gov

What this trial studies

This phase II clinical trial evaluates the safety and efficacy of delivering a radiation therapy boost to the supraclavicular area in high-risk cN3c breast cancer patients who have not achieved complete clinical response after primary systemic therapy. Participants will be categorized based on their nodal response to treatment and will receive a cumulative radiation dose of at least 60 Gy if deemed high risk. The study aims to determine if this targeted approach can improve overall survival rates in this patient population.

Who should consider this trial

Good fit: Ideal candidates are females aged 18 and older with histologically confirmed cN3c breast cancer who did not achieve complete clinical response in supraclavicular lymph nodes after neoadjuvant therapy.

Not a fit: Patients who have achieved complete clinical response in supraclavicular lymph nodes or those with other types of breast cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival outcomes for high-risk breast cancer patients.

How similar studies have performed: Previous studies have indicated that targeted radiation boosts can improve survival in similar patient populations, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Voluntary participation with documented informed consent.
* Females aged ≥18 years.
* Histological or cytological confirmed primary breast carcinoma.
* Clinical diagnosis of cN3c.
* Receipt of neoadjuvant therapy, guided by the attending physician and current treatment guidelines.
* Did not achieve cCR in SCLN following neoadjuvant therapy.
* Undergoing curative-intent breast cancer surgery post-neoadjuvant therapy.
* Pathological evaluation of axillary lymph nodes post-surgery.
* KPS score ≥80, with expected survival exceeding 2 years.
* Complete healing of surgical incision without complications.
* Negative pathological surgical margins.
* Availability of hormonal receptor (ER/PR), HER2, and Ki-67 status for the primary breast lesion.
* Pre-menopausal females required to practice contraception for at least one month prior to screening, maintaining contraception throughout the study and for a specified period post-study cessation.

Exclusion Criteria:

* Patients with confirmed distant metastases by pathology or imaging.
* Those who have not received neoadjuvant systemic therapy.
* Patients who have not undergone curative-intent surgery.
* Pregnant or lactating women.
* Individuals with severe non-neoplastic comorbidities affecting radiotherapy implementation.
* History of malignancy within the past 5 years (excluding ductal carcinoma in situ, basal cell carcinoma, squamous cell carcinoma in situ, cervical carcinoma in situ, and in situ adenocarcinoma of the lung).
* Simultaneous contralateral breast cancer.
* History of prior radiation therapy to the neck, chest, or ipsilateral axilla.
* Active collagen vascular disease.
* Patients with T4 staging of the primary tumor.
* Inability to initiate radiotherapy within 12 weeks post breast cancer curative surgery (breast-conserving surgery or mastectomy), or within 8 weeks post completion of adjuvant chemotherapy.

Where this trial is running

Shanghai, Shanghai Municipality

• Ruijin hospital, Shanghai jiaotong university school of medicine — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Shuyan Li, MD

Conditions: Breast Cancer, cN3c, Boost irradiation, breast cancer, high risk