Status:
UNKNOWN
Radiotherapy Versus Low-Dose Tamoxifen Following Breast Conserving Surgery for Low-Risk Breast Ductal Carcinoma in Situ
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
Tri-Service General Hospital
Koo Foundation Sun Yat-Sen Cancer Center
Conditions:
Breast Ductal Carcinoma in Situ
Eligibility:
FEMALE
40+ years
Phase:
PHASE3
Brief Summary
Although the results obtained from ECOG E5194 cohort 1 (criteria: mammographically detected low- or intermediate-grade DCIS, measuring less than 2.5 cm with margins ≥ 3 mm) and RTOG 9804 trial (the sa...
Detailed Description
\[Background\] Radiotherapy (RT) following breast conserving surgery (BCS) is commonly used in ductal carcinoma in situ (DCIS) of breast to decrease local recurrence. Previous retrospective studies su...
Eligibility Criteria
Inclusion
- Women
- New histologically diagnosed breast ductal carcinoma in situ (DCIS).
- Age ≥ 40 years
- Low risks of BRCA (breast cancer)1 and BRCA2: Manchester Score \< 10
- The DCIS must be detected by mammogram and must be unicentric, and no-mass lesion.
- Status post breast conserving surgery
- Pathological characteristics (all characteristics) 7.1 Lesions ≤ 2.5 cm in greatest dimension on pathologic specimen (use the largest measured size from the pathology report to obtain the required measurement of ≤ 2.5 cm).
- 2 Must be classified as low or intermediate nuclear grade DCIS but without comedo necrosis according to Pathologic Guidelines (section 9.2.2) 7.3 Margins as assessed by the ink method will be 3 mm or greater. 7.4 Must be estrogen receptor (ER)-positive DCIS, ER percentage must be ≥10%
- Clinically node negative.
Exclusion
- Known BRCA1 or BRCA2 mutation
- Age \< 40 years
- Women whose DCIS is palpable at the time of diagnosis, or multi-centric (mammography), or mass (mammography), or who have bloody nipple discharge.
- Pathological characteristics 4.1 Lesions measuring greater than 2.5 cm in greatest dimension on pathologic specimen.
- 2.High-grade lesions or low to intermediate grade with comedo necrosis as classified by the Guidelines.
- 3. Margins as assessed by the ink method will be less than 3 mm. 4.4. ER-negative DCIS or ER-positive percentage \< 10% in tumor cells
- Post-mastectomy patients
- Prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer.
- Evidence of clinically significant cardiac disease, as defined by cardiac disease (New York Cardiac disease grade II), history of myocardial infarction, cerebral stroke, unstable arrhythmia, and unstable angina pectoris within 12 months before study entry.
- Pregnant or lactating status.
Key Trial Info
Start Date :
April 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
810 Patients enrolled
Trial Details
Trial ID
NCT04046159
Start Date
April 30 2019
End Date
December 31 2025
Last Update
August 6 2019
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100