POTENT(Postoperative Therapy with Endocrine and TS-1)

JRCT ID: jRCTs051180057

Registered date:13/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: breast cancer
• Date of first enrollment: 01/02/2012
• Target sample size: 1860
• Study type: Interventional

Intervention(s)

To verify that the combination of standard postoperative endocrine therapy and S-1 increases the recurrence-
inhibitory effect compared to standard postoperative endocrine therapy alone in a randomized comparison study.

Outcome(s)

• Primary Outcome: Invasive Disease-free survival

Secondary Outcome

Safety criteria: Frequency and severity of adverse events and adverse reactions
Efficacy criteria: Overall survival, distant disease-free survival, disease-free survival, and relationship of tumor growth factors and biomarkers with the recurrence-inhibitory effect of S-1.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Female

Include criteria

[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

Exclude criteria

[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

Related Information

• Primary Sponsor: Toi Masakazu
• Source(s) of Monetary Support: TAIHO PHARMACEUTICAL CO., LTD.,TAIHO PHARMACEUTICAL CO., LTD.,TAIHO PHARMACEUTICAL CO., LTD.,TAIHO PHARMACEUTICAL CO., LTD.,TAIHO PHARMACEUTICAL CO., LTD.,TAIHO PHARMACEUTICAL CO., LTD.
• Secondary ID(s): UMIN000003969