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Radiotherapy Versus Low-Dose Tamoxifen Following Breast Conserving Surgery for Low-Risk Breast Ductal Carcinoma in Situ

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ClinicalTrials.gov Identifier: NCT04046159
Recruitment Status : Recruiting
First Posted : August 6, 2019
Last Update Posted : August 6, 2019
Sponsor:
Collaborators:
Tri-Service General Hospital
Koo Foundation Sun Yat-Sen Cancer Center
Kaohsiung Medical University
Kyoto University
Mackay Memorial Hospital
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
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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 same enrolled clinicopathological features to cohort 1 of ECOG E5194 trial) demonstrated that the 7-year ipsilateral breast tumor recurrence (IBTR) ranged from 5.6% to 10.5% for low-risk ductal carcinoma in situ (DCIS) patients, the aforementioned two studies included a proportional patients who had young age and negative estrogen receptor (ER) status tumor. Previous studies and our studies revealed that age < 40 years and ER-negative status in tumor were independent prognostic factor for recurrence of breast DCIS irrespective of tumor characteristics. The UK/ANZ randomized trial, enrolling high-risk and low-risk clinicopathologic features of DCIS, demonstrated that a benefit of tamoxifen in terms of reducing the IBTR is observed in the BCS alone group but not found in the BCS plus RT group. A recent published randomized trial showed that tamoxifen at the dose of 5 mg/day for 3 years.

Based on the aforementioned results, we hypothesized that the administration of tamoxifen is not inferior than the prescription of RT in terms of reducing the IBTR for DCIS patients who had age more than 40 years, the pathological features meeting the ECOG E5194 cohort 1 criteria, and positive ER status in tumors. To approve the hypothesis, we will design a randomized non-inferiority trial to assess whether the effect of administration of tamoxfien (5 mg per day) for 10 years following BCS is not inferior in terms of reducing IBTR when comparing RT following BCS for patients who had low-risk clinicopathologic features (age more than 40 years and ECOG E5194 cohort 1 criteria) and positive-ER status of breast DCIS.


Condition or disease Intervention/treatment Phase
Breast Ductal Carcinoma in Situ Drug: Low-dose tamoxifen Radiation: Whole breast radiotherapy Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 810 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Non-inferiority trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiotherapy Versus Low-Dose Tamoxifen Following Breast Conserving Surgery for Low-Risk and Estrogen Receptor-Positive Ductal Carcinoma in Situ of Breast: an International Open-label Randomized Non-inferiority Trial
Actual Study Start Date : April 30, 2019
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Radiotherapy arm
Radiotherapy for ipsilateral whole breast with 50 Gy/25 fractions or 40.05 Gy/15 fractions
 Radiation: Whole breast radiotherapy
Ipsilateral breast tumor recurrence and side effect
Other Name: WBRT
Experimental: Tamoxifen arm
Tamoxifen 5 mg QD for 10 years
 Drug: Low-dose tamoxifen
Low-dose tamoxifen is not inferior than radiotherapy in decreasing ipsilateral breast tumor recurrence and side effect
Other Name: LDT


Outcome Measures
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Primary Outcome Measures :
  1. Breast tumor recurrence [ Time Frame: through study completion, an average of 1 year ]
    Ispilateral, regional recurrence, contralateral recurrence, and distant recurrence [DCIS or invasive cancer event]


Secondary Outcome Measures :
  1. The overall survival [ Time Frame: through study completion, an average of 1 year ]
    Overall survival

  2. Adverse effects [ Time Frame: through study completion, an average of 1 year ]
    Adverse effects of radiotherapy and tamoxifen


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women
  2. New histologically diagnosed breast ductal carcinoma in situ (DCIS).
  3. Age ≥ 40 years
  4. Low risks of BRCA (breast cancer)1 and BRCA2: Manchester Score < 10
  5. The DCIS must be detected by mammogram and must be unicentric, and no-mass lesion.
  6. Status post breast conserving surgery

  7. 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).

    7.2 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%

  8. Clinically node negative.

Exclusion Criteria:

  1. Known BRCA1 or BRCA2 mutation
  2. Age < 40 years
  3. Women whose DCIS is palpable at the time of diagnosis, or multi-centric (mammography), or mass (mammography), or who have bloody nipple discharge.

  4. Pathological characteristics 4.1 Lesions measuring greater than 2.5 cm in greatest dimension on pathologic specimen.

    4.2.High-grade lesions or low to intermediate grade with comedo necrosis as classified by the Guidelines.

    4.3. 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

  5. Post-mastectomy patients
  6. Prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer.
  7. 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.
  8. Pregnant or lactating status.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04046159


Contacts
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Contact: Chiun-Sheng Huang, MD, PhD, MPH +(886)-2-87339036 huangcs@ntu.edu.tw
Contact: Sung-Hsin Kuo, M.D.,Ph.D +886-223123456 ext 67144 shkuo101@ntu.edu.tw

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Sung-Hsin Kuo, M.D.,Ph.D.    +(886)-223123456 ext 67144    shkuo101@ntu.edu.tw   
Principal Investigator: Chiun-Sheng Huang, MD, PhD, MPH         
Sponsors and Collaborators
National Taiwan University Hospital
Tri-Service General Hospital
Koo Foundation Sun Yat-Sen Cancer Center
Kaohsiung Medical University
Kyoto University
Mackay Memorial Hospital
Investigators
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Principal Investigator: Chiun-Sheng Huang, MD, PhD, MPH Department of Surgery, National Taiwan University Hospital
More Information
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT04046159     History of Changes
Other Study ID Numbers: 201902048MINC
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Share participant data
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: 5 years after completion of study
Access Criteria: Will be available after contacting with Principle investigators

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Ductal, Breast
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Breast Carcinoma In Situ
Breast Neoplasms
Neoplasms by Site
 Breast Diseases
Skin Diseases
Tamoxifen
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents