Follow-up survey following the completion of 'A open-label, randomized controlled study of adjuvant therapy with TAP-144-SR (3M) in premenopausal breast cancer patients'

Follow-up survey following the completion of 'A open-label, randomized controlled study of adjuvant therapy with TAP-144-SR (3M) in premenopausal breast cancer patients' - Follow-up survey following TAP-144-SR (3M) study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000006050

Enrollment

222

Registered

2011-10-01

Start date

2013-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postsurgical of premenopausal breast cancer

Interventions

None listed

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) &#8211; 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
Disease-Free Survival	—

Countries

Japan

Contacts

Public ContactJunichi Kurebayashi

Kawasaki Medical School Department of Breast and Thyroid Surgery

nomail@no086-462-1111

Outcome results