A Phase 3 Comparative Study of TAP-144-SR(6M) in Postoperative and Hormone Therapy-naïve Patients With Premenopausal Breast Cancer

This study is currently recruiting participants.
Verified October 2013 by Takeda
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01546649
First received: February 28, 2012
Last updated: October 11, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Premenopausal Breast Cancer
Drug: TAP-144-SR(6M)
Drug: TAP-144-SR(3M)
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • The suppression rate of serum estradiol(E2) to menopausal level [ Time Frame: from Week 4 through Week 48 ] [ Designated as safety issue: No ]
    Comparison of the proportion of patients maintained at menopausal level


Estimated Enrollment: 164
Study Start Date: March 2012
Arms Assigned Interventions
Experimental: TAP-144-SR(6M)
TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 96 weeks.
Drug: TAP-144-SR(6M)
Active Comparator: TAP-144-SR(3M)
TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 96 weeks.
Drug: TAP-144-SR(3M)

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01546649

Contacts
Contact: Takeda Study Registration Call Center +1-800-778-2860 medicalinformation@tpna.com

Locations
Japan
Recruiting
Nagoya-shi, Aichi, Japan
Recruiting
Fukushima-shi, Fukushima, Japan
Active, not recruiting
Maebashi-shi, Gunma, Japan
Recruiting
Ohta-shi, Gunma, Japan
Recruiting
Sapporo-shi, Hokkaido, Japan
Recruiting
Isehara-shi, Kanagawa, Japan
Active, not recruiting
Yokohama-shi, Kanagawa, Japan
Recruiting
Kumamoto-shi, Kumamoto, Japan
Recruiting
Kyoto-shi, Kyoto, Japan
Recruiting
Nigata-shi, Nigata, Japan
Recruiting
Kurashiki-shi, Okayama, Japan
Recruiting
Osaka-shi, Osaka, Japan
Recruiting
Suita-shi, Osaka, Japan
Active, not recruiting
Kita-adachi-gun, Saitama, Japan
Recruiting
Shinjuku-ku, Tokyo, Japan
Sponsors and Collaborators
Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01546649     History of Changes
Other Study ID Numbers: TAP-144-SR(6M)IP/CPH-202, JapicCTI-121762, U1111-1128-7039
Study First Received: February 28, 2012
Last Updated: October 11, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Leuprolide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014