POTENT(Postoperative Therapy with Endocrine and TS-1)
- Conditions
- breast cancer
- Registration Number
- JPRN-jRCTs051180057
- Lead Sponsor
- Toi Masakazu
- Brief Summary
While serious AEs occurred significantly more often in the S-1 group compared with the control group and thus safety profile deserves sufficient consideration, this study has proven that the concurrent administration of standard postoperative endocrine therapy with S-1 increases the recurrence-inhibitory effect compared with standard postoperative endocrine therapy alone in patients with ER-positive and HER2-negative primary breast cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 1959
[Target disease]
Estrogen receptor-positive, HER2-negative primary breast cancer
[Inclusion criteria]
1) Females histologically diagnosed with invasive breast cancer
2) Stage I to Stage IIIA at first diagnosis and Stage IIIB with a radical operation performed
3) ER-positive
4) HER2-negative
5) The risk of recurrence is intermediate or higher
6) A test performed within 14 days before registration shows the conservation of the major organ functions
7) Written consent has been obtained from the patient
[Exclusion criteria]
1) Active double cancer
2) Bilateral (synchronous/dyschronous) breast cancer and inflammatory breast cancer
3) More than 2 weeks of prior treatment with oral 5-FU (patients with a history of prior treatment with intravenous 5-FU are eligible for registration)
4) Serious diarrhea
5) Serious complications
6) Past medical history such as myocardial infarction, interstitial pneumonia, or allergy to fluorinated pyrimidines
7) Pregnant women, lactating women, or women desiring pregnancy
8) Patients judged by the physician to be inappropriate for registration in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method