Postsurgical of premenopausal breast cancer
Conditions
Interventions
investigational material(s)
Generic name etc : TAP-144-SR (3M)
INN of investigational material : Leuprorelin asetate
Therapeutic category code : 249 Other hormone preparations (including antihormone p
Sponsors
Takeda Pharmaceutical Company Limited
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) The subject has a histologically confirmed primary breast cancer. 2) The subject has either Estrogen Receptor (ER) -positive or Progesterone Receptor (PgR) –positive primary tumor. 3) The subject has T1~T3, N not required, M0 tumor determined by the TNM classification (UICC, Sixth Edition, 2002,). The number of axillary lymph node involved is not limited. 4) Any operative procedure for breast cancer is acceptable. 5) Status of preoperative treatment and postoperative adjuvant chemotherapy prior to the study enrollment are not required. 6) The subject is able to receive the study drug and Tamoxifen (TAM) within 12 weeks after surgery or after postoperative adjuvant chemotherapy prior to the study enrollment.. 7) The subject has a history of regular menstrual periods within 12 weeks prior to study enrollment, or the subject has FSH of less than 40 mIU/mL and E2 of 10 pg/mL or more measured within 12 weeks prior to study enrollment. 8) The subject has Performance Status (P.S.) of Grade 0 or 1.
Exclusion criteria
Exclusion criteria: 1) The subject has received preoperative hormone therapy prior to breast cancer surgery. 2) The subject has received postoperative adjuvant hormone therapy prior to the study enrollment. 3) The subject has received bilateral oophorectomy and irradiation to bilateral ovaries. 4) The subject has inflammatory breast cancer or bilateral breast cancer. 5) The subject has double cancer or has a history of carcinoma in other organs. 6) The subject is pregnant or breast-feeding, and of child-bearing potential. 7) The subject has past history of hypersensitivity to the study drug component or synthetic LH-RH, LH-RH derivative, and TAM or TAM analogue (antiestrogen). 8) The subject has severe complications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety:Adverse event Efficacy:DFS | — |
Outcome results
None listed