To hear about similar clinical trials, please enter your email below
Trial Title:
Boost Irradiation to the Supraclavicular Area Among High Risk cN3c Breast Cancer Patients
NCT ID:
NCT06404697
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
cN3c
Boost irradiation
breast cancer
high risk
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Boost irradiation
Description:
High-risk patients will undergo boost irradiation to the SCV with a cumulative dose of
≥60 Gy.
Arm group label:
High-risk
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.
Detailed description:
This study is a phase II single-arm, prospective clinical trial aimed at assessing the
efficacy and safety of RT boost to the SCV area among high-risk cN3c breast cancer
patients contingent upon the nodal response after PST.
Our previous retrospective study revealed that nodal response to PST serves as an
independent prognostic factor for survival and pattern of failure. A cumulative SCV dose
of ≥60 Gy has been associated with improved overall survival (OS) in subgroup of patients
who did not achieve SCLN cCR.
Based on nodal response to PST, patients will be categorized into three groups: those who
did not achieve cCR in SCLN (considered high risk), those who achieved SCLN cCR but did
not attain pCR in ALN (considered intermediate risk), and those who achieved cCR in SCLN
and pCR in ALN (considered low risk). High-risk patients will undergo boost irradiation
to the SCV with a cumulative dose of ≥60 Gy.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ruijin hospital, Shanghai jiaotong university school of medicine
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiayi Chen, MD
Start date:
May 2024
Completion date:
April 2030
Lead sponsor:
Agency:
Ruijin Hospital
Agency class:
Other
Source:
Ruijin Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06404697
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10344941/
