NCT06404697 Boost Irradiation to the Supraclavicular Area Among High Risk cN3c Breast Cancer Patients
| NCT ID | NCT06404697 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Ruijin Hospital |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2024-05 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 24 participants in total. It began in 2024-05 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
cN3c breast cancer with ipsilateral supraclavicular (SCV) lymph nodal (SCLN) metastasis is known to have a dismal prognosis. Currently, the combined-modality therapy consisting of primary systemic therapy (PST), subsequent local and/or systemic therapy based on response is the standard of care. However, the value of giving radiotherapy (RT) boost to SCV region remains uncertain in cN3c patients. This study aimed to assess the efficacy and safety of RT boost to the SCV area in high-risk cN3c breast cancer patients based on nodal response following PST.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06404697 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06404697 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06404697 currently recruiting?
Yes, NCT06404697 is actively recruiting participants. Contact the research team at lsy12284@rjh.com.cn for enrollment information.
Where is the NCT06404697 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06404697 clinical trial?
NCT06404697 is sponsored by Ruijin Hospital. The trial plans to enroll 24 participants.
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