A Phase 3 Comparative Study of TAP-144-SR(6M) in Postoperative and Hormone Therapy-naïve Patients With Premenopausal Breast Cancer
Condition: Premenopausal Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: TAP-144-SR(6M); TAP-144-SR(3M)
Intervention MeSH terms: Leuprolide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 167.0
Sex: Female
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      Hormone dynamics, pharmacokinetics, safety, and efficacy of TAP-144-SR(6M) will be evaluated
      against TAP-144-SR(3M) in postoperative and hormone therapy-naïve patients with premenopausal
      breast cancer
    

Eligibility criteria:

        Inclusion Criteria:

          1. The participant has histopathologically-confirmed primary breast cancer in Japanese.

          2. The participant is aged 20 years or older when informed consent is obtained

          3. The participant has estrogen receptor (ER)-positive tumor cells and/or progesterone
             receptor (PgR)-positive primary tumor. And HER-2 is negative.

          4. The participant has breast cancer in the clinical stages of T1-T3, N-any and M0 by TNM
             classification (the seventh edition, proposed by UICC in 2009). (No distant metastasis
             to lung, liver and bone should be confirmed on the image-based diagnosis at study
             enrollment. The image taken within 12 weeks prior to study enrollment is also
             available for the diagnosis.) The number of axillary lymph node metastasis is not
             limited.

          5. Any operative procedure for breast cancer is acceptable. In principle, after
             breast-conserving surgery, the participant will receive postoperative radiation to the
             conserving breast.

          6. Neoadjuvant chemotherapy and adjuvant chemotherapy prior to study enrollment are
             acceptable. (It is advisable the same kind of chemotherapy is performed at each site.)

          7. The participant has a history of regular menstrual periods within 12 weeks prior to
             study enrollment, or the participant has FSH of less than 40 mIU/mL and E2 of 10 pg/mL
             or more measured within 12 weeks prior to study enrollment. The participant has not
             had a chemical menopause (i.e., FSH of less than 40 mIU/mL and E2 of 10 pg/mL or more)
             within 12 weeks after completing adjuvant chemotherapy.

          8. The participant is in a condition to receive study drug and Tamoxifen (TAM) within 12
             weeks after surgery or after adjuvant chemotherapy prior to study enrollment. Adjuvant
             chemotherapy prior to study is required to have been completed at the time of study
             enrollment.

          9. The participant has ECOG performance status of grades 0 or 1 at the time of study
             enrollment.

         10. The participant meets the following criteria of hepatic, renal and bone marrow
             functions on the laboratory test results at screening:

               -  Hepatic function: AST (GOT) ≤ 3.0 times the upper limit of normal (ULN) ALT (GPT)
                  ≤ 3.0 times the ULN

               -  Renal function: serum creatinine level < 1.5 times the ULN

               -  Bone marrow function : white blood cell count ≥ 3,000/mm3 platelet count ≥
                  100,000/μL hemoglobin ≥ 10.0g/dL

         11. The participant agrees to use a non-hormonal method of contraception through the study
             period.

        Exclusion Criteria:

          1. The participant has received neoadjuvant or adjuvant hormonal therapy for the latest
             breast cancer surgery.

          2. The participant has received bilateral oophorectomy and bilateral ovarian irradiation.

          3. The participant has inflammatory breast cancer or bilateral breast cancer.

          4. The participant has non-invasive ductal carcinoma.

          5. The participant has multiple primary cancers, or a history of carcinoma in other
             organs.

          6. The participant is pregnant or breast-feeding.

          7. The participant has a history of hypersensitivity to synthetic LH-RH, LH-RH
             derivative, TAM, TAM analogue (antiestrogen) or any component of the study drug.

          8. The participant has a history of, or has been diagnosed with thromboembolism including
             myocardial infarction, cerebral infarction, venous thrombosis, and pulmonary embolism,
             or cardiac failure.

          9. Patients whose QTcF interval exceeded 460 msec on the 12-lead electrocardiogram at
             screening.