Boost Irradiation to the Supraclavicular Area Among High Risk cN3c Breast Cancer Patients

NCT06404697 | Recruiting Phase 2

• 1 other identifier: RuijinH 2024(026)
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

cN3c; Boost irradiation; breast cancer; high risk

Outcome Measures

Primary Outcomes (1)

• 2-year recurrence-free survival

  RFS were calculated from the date of surgery to the date of first documented recurrence (including regional, local and distant) or mortality, whichever happens first. In the case of patients who had not encountered recurrence or death, specifically in terms of recurrence-free survival, the time of the last tumor assessment was considered as the endpoint. Tumor response was evaluated by investigators following RECIST v1.1 criteria.

  2 years

Secondary Outcomes (4)

• Overall survival

  2 years

• Late toxicity

  2 years

• Acute toxicity

  6 months

• Quality of Life (QoL)

  2 years

Study Arms (1)

High-risk

EXPERIMENTAL

High-risk patients will undergo boost irradiation to the SCV with a cumulative dose of ≥60 Gy.

Radiation: Boost irradiation

Interventions

Boost irradiation RADIATION

High-risk patients will undergo boost irradiation to the SCV with a cumulative dose of ≥60 Gy.

High-risk

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin hospital, Shanghai jiaotong university school of medicine

Shanghai, Shanghai Municipality, China

RECRUITING

Related Links

• This is our retrospective study relevant to this trial

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Shuyan Li, MD

CONTACT

8615253185831; lsy12284@rjh.com.cn

Study Design

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

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: May 8, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2030
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

CN (1)