Radiotherapy versus low-dose tamoxifen following breast-conserving surgery for low-risk and estrogen receptor-positive breast ductal carcinoma in situ: an international open-label randomized non-inferiority trial (TBCC-ARO DCIS Trial)
Abstract Background Radiotherapy (RT) following breast-conserving surgery (BCS) is mainly used to decrease the rate of ipsilateral breast tumor recurrence (IBTR) in women with breast ductal carcinoma in situ (DCIS). Recent studies have demonstrated that low-dose tamoxifen significantly reduces IBTR...
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| Format: | Article |
| Language: | English |
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BMC
2023-09-01
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| Series: | BMC Cancer |
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| Online Access: | https://doi.org/10.1186/s12885-023-11291-6 |
| _version_ | 1797452347131035648 |
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| author | Sung-Hsin Kuo Ling-Ming Tseng Shou-Tung Chen Yasuaki Sagara Yuan-Ching Chang Hsien-Tang Yeh Yao-Lung Kuo Chih-Chiang Hung Tzu-Pin Lu Yi-Hsuan Lee Masakazu Toi Chiun-Sheng Huang |
| author_facet | Sung-Hsin Kuo Ling-Ming Tseng Shou-Tung Chen Yasuaki Sagara Yuan-Ching Chang Hsien-Tang Yeh Yao-Lung Kuo Chih-Chiang Hung Tzu-Pin Lu Yi-Hsuan Lee Masakazu Toi Chiun-Sheng Huang |
| author_sort | Sung-Hsin Kuo |
| collection | DOAJ |
| description | Abstract Background Radiotherapy (RT) following breast-conserving surgery (BCS) is mainly used to decrease the rate of ipsilateral breast tumor recurrence (IBTR) in women with breast ductal carcinoma in situ (DCIS). Recent studies have demonstrated that low-dose tamoxifen significantly reduces IBTR in breast DCIS. Here, we aim to determine whether the administration of low-dose tamoxifen is non-inferior to RT in preventing IBTR in patients with low-risk characteristics of breast DCIS. Methods/design This is a prospective, international, open-label, randomized, non-inferiority trial. Patients with low-risk clinicopathologic features (> 40 years old, low risk of breast cancer susceptibility gene (BRCA) 1 and BRCA2 mutations, mammographically detected unicentric and non-mass lesions, low- or intermediate-grade without comedo or necrosis, measuring < 2.5 cm with margins ≥ 3 mm, and estrogen receptor-positive status) of DCIS who underwent BCS will be randomized at a 1:1 ratio to either receive tamoxifen (5 mg/day) for 5 years or undergo RT with conventional fractions (50 Gy in 25 fractions) or hypofractionations (40.05 Gy in 15 fractions). Randomization will be stratified by the Taiwan Breast Cancer Consortium. As approximately 5% of patients cannot tolerate the side effects of low-dose tamoxifen and will receive RT, we estimate that 405 patients will be randomized to a low-dose tamoxifen arm and 405 patients to the RT arm, according to a non-inferiority margin within 5% of IBTR difference and 90% β-power noticing non-inferiority. The primary endpoints are breast tumor recurrence, including ipsilateral, regional, contralateral, and distant recurrence of breast DCIS or invasive cancer. The secondary endpoints are overall survival and adverse effects of RT and tamoxifen. Translational studies will also be conducted for this trial. Discussion This is the first non-inferiority trial on breast DCIS. This study will provide an important recommendation for clinical physicians on whether to use low-dose adjuvant tamoxifen for patients with low-risk breast DCIS who do not want to receive adjuvant RT. Trial registration ClinicalTrials.gov, ID: NCT04046159, Registered on April 30, 2019. |
| first_indexed | 2024-03-09T15:07:09Z |
| format | Article |
| id | doaj.art-f9af8084572e4290962908f31afcfc0d |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-03-09T15:07:09Z |
| publishDate | 2023-09-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-f9af8084572e4290962908f31afcfc0d2023-11-26T13:36:58ZengBMCBMC Cancer1471-24072023-09-0123111010.1186/s12885-023-11291-6Radiotherapy versus low-dose tamoxifen following breast-conserving surgery for low-risk and estrogen receptor-positive breast ductal carcinoma in situ: an international open-label randomized non-inferiority trial (TBCC-ARO DCIS Trial)Sung-Hsin Kuo0Ling-Ming Tseng1Shou-Tung Chen2Yasuaki Sagara3Yuan-Ching Chang4Hsien-Tang Yeh5Yao-Lung Kuo6Chih-Chiang Hung7Tzu-Pin Lu8Yi-Hsuan Lee9Masakazu Toi10Chiun-Sheng Huang11Department of Oncology, National Taiwan University HospitalDepartment of Surgery, Taipei Veterans General HospitalDepartment of Surgery, Changhua Christian HospitalDepartment of Breast Surgical Oncology, Hakuaikai Social Cooperation, Sagara HospitalDepartment of Surgery, Mackay Memorial HospitalDepartment of Surgery, Lotung Poh-Ai HospitalDivision of Breast Surgery, Department of Surgery, National Cheng Kung University HospitalDepartment of Surgery, Division of Breast Surgery, Taichung Veterans General HospitalDepartment of Public Health, National, Institute of Epidemiology and Preventive Medicine, Taiwan UniversityDepartment of Pathology, National Taiwan University Hospital and National Taiwan University, College of MedicineTokyo Metropolitan Cancer and Infectious Disease Centre, Komagome HospitalDepartment of Surgery, National Taiwan University Hospital and National Taiwan University College of MedicineAbstract Background Radiotherapy (RT) following breast-conserving surgery (BCS) is mainly used to decrease the rate of ipsilateral breast tumor recurrence (IBTR) in women with breast ductal carcinoma in situ (DCIS). Recent studies have demonstrated that low-dose tamoxifen significantly reduces IBTR in breast DCIS. Here, we aim to determine whether the administration of low-dose tamoxifen is non-inferior to RT in preventing IBTR in patients with low-risk characteristics of breast DCIS. Methods/design This is a prospective, international, open-label, randomized, non-inferiority trial. Patients with low-risk clinicopathologic features (> 40 years old, low risk of breast cancer susceptibility gene (BRCA) 1 and BRCA2 mutations, mammographically detected unicentric and non-mass lesions, low- or intermediate-grade without comedo or necrosis, measuring < 2.5 cm with margins ≥ 3 mm, and estrogen receptor-positive status) of DCIS who underwent BCS will be randomized at a 1:1 ratio to either receive tamoxifen (5 mg/day) for 5 years or undergo RT with conventional fractions (50 Gy in 25 fractions) or hypofractionations (40.05 Gy in 15 fractions). Randomization will be stratified by the Taiwan Breast Cancer Consortium. As approximately 5% of patients cannot tolerate the side effects of low-dose tamoxifen and will receive RT, we estimate that 405 patients will be randomized to a low-dose tamoxifen arm and 405 patients to the RT arm, according to a non-inferiority margin within 5% of IBTR difference and 90% β-power noticing non-inferiority. The primary endpoints are breast tumor recurrence, including ipsilateral, regional, contralateral, and distant recurrence of breast DCIS or invasive cancer. The secondary endpoints are overall survival and adverse effects of RT and tamoxifen. Translational studies will also be conducted for this trial. Discussion This is the first non-inferiority trial on breast DCIS. This study will provide an important recommendation for clinical physicians on whether to use low-dose adjuvant tamoxifen for patients with low-risk breast DCIS who do not want to receive adjuvant RT. Trial registration ClinicalTrials.gov, ID: NCT04046159, Registered on April 30, 2019.https://doi.org/10.1186/s12885-023-11291-6Ductal carcinoma in situBreastTamoxifenRadiotherapyLow-risk |
| spellingShingle | Sung-Hsin Kuo Ling-Ming Tseng Shou-Tung Chen Yasuaki Sagara Yuan-Ching Chang Hsien-Tang Yeh Yao-Lung Kuo Chih-Chiang Hung Tzu-Pin Lu Yi-Hsuan Lee Masakazu Toi Chiun-Sheng Huang Radiotherapy versus low-dose tamoxifen following breast-conserving surgery for low-risk and estrogen receptor-positive breast ductal carcinoma in situ: an international open-label randomized non-inferiority trial (TBCC-ARO DCIS Trial) BMC Cancer Ductal carcinoma in situ Breast Tamoxifen Radiotherapy Low-risk |
| title | Radiotherapy versus low-dose tamoxifen following breast-conserving surgery for low-risk and estrogen receptor-positive breast ductal carcinoma in situ: an international open-label randomized non-inferiority trial (TBCC-ARO DCIS Trial) |
| title_full | Radiotherapy versus low-dose tamoxifen following breast-conserving surgery for low-risk and estrogen receptor-positive breast ductal carcinoma in situ: an international open-label randomized non-inferiority trial (TBCC-ARO DCIS Trial) |
| title_fullStr | Radiotherapy versus low-dose tamoxifen following breast-conserving surgery for low-risk and estrogen receptor-positive breast ductal carcinoma in situ: an international open-label randomized non-inferiority trial (TBCC-ARO DCIS Trial) |
| title_full_unstemmed | Radiotherapy versus low-dose tamoxifen following breast-conserving surgery for low-risk and estrogen receptor-positive breast ductal carcinoma in situ: an international open-label randomized non-inferiority trial (TBCC-ARO DCIS Trial) |
| title_short | Radiotherapy versus low-dose tamoxifen following breast-conserving surgery for low-risk and estrogen receptor-positive breast ductal carcinoma in situ: an international open-label randomized non-inferiority trial (TBCC-ARO DCIS Trial) |
| title_sort | radiotherapy versus low dose tamoxifen following breast conserving surgery for low risk and estrogen receptor positive breast ductal carcinoma in situ an international open label randomized non inferiority trial tbcc aro dcis trial |
| topic | Ductal carcinoma in situ Breast Tamoxifen Radiotherapy Low-risk |
| url | https://doi.org/10.1186/s12885-023-11291-6 |
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