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

NCT01546649 | Completed Phase 3 Results

• 3 other identifiers: TAP-144-SR(6M)IP/CPH-202JapicCTI-121762U1111-1128-7039
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 15

Brief 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

Conditions

Premenopausal Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Suppressive Effect of Serum Estradiol (E2) to Menopausal Level (=<30 pg/mL) From Week 4 Through Week 48

  Comparison of both the treatment groups was done by assessing the suppressive effect on serum E2 concentration maintained at menopausal level (=\<30pg/mL). Suppression rate was calculated as proportion of participants maintained at menopausal level.

  Week 4 up to Week 48

Secondary Outcomes (7)

• Concentration of Serum E2

  Baseline, Hour (hr) 1, 3, 6 on Day 1, Day 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, 169, 176, 183, 197, 225, 253, 281, 309, 337, 421, 505, 589 and 673

• Concentration of Serum Luteinizing Hormone (LH)

  Baseline, Hour 1, 3, 6 on Day 1, Day 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, 169, 176, 183, 197, 225, 253, 281, 309, 337, 421, 505, 589 and 673

• Concentration of Follicle Stimulating Hormone (FSH)

  Baseline, Hour 1, 3, 6 on Day 1, Day 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, 169, 176, 183, 197, 225, 253, 281, 309, 337, 421, 505, 589 and 673

• Disease Free Survival (DFS) Rate at Week 96

  Week 96

• Distant Disease Free Survival (DDFS) Rate at Week 96

  Week 96

Study Arms (2)

TAP-144-SR(6M)

EXPERIMENTAL

TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 96 weeks.

Drug: TAP-144-SR(6M)

TAP-144-SR(3M)

ACTIVE COMPARATOR

TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 96 weeks.

Drug: TAP-144-SR(3M)

Interventions

TAP-144-SR(6M) DRUG

TAP-144-SR(6M)

TAP-144-SR(3M) DRUG

TAP-144-SR(3M)

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant has histopathologically-confirmed primary breast cancer in Japanese.
• The participant is aged 20 years or older when informed consent is obtained
• The participant has estrogen receptor (ER)-positive tumor cells and/or progesterone receptor (PgR)-positive primary tumor. And HER-2 is negative.
• 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.
• Any operative procedure for breast cancer is acceptable. In principle, after breast-conserving surgery, the participant will receive postoperative radiation to the conserving breast.
• Neoadjuvant chemotherapy and adjuvant chemotherapy prior to study enrollment are acceptable. (It is advisable the same kind of chemotherapy is performed at each site.)
• 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.
• 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.
• The participant has ECOG performance status of grades 0 or 1 at the time of study enrollment.
• 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
• The participant agrees to use a non-hormonal method of contraception through the study period.

You may not qualify if:

• The participant has received neoadjuvant or adjuvant hormonal therapy for the latest breast cancer surgery.
• The participant has received bilateral oophorectomy and bilateral ovarian irradiation.
• The participant has inflammatory breast cancer or bilateral breast cancer.
• The participant has non-invasive ductal carcinoma.
• The participant has multiple primary cancers, or a history of carcinoma in other organs.
• The participant is pregnant or breast-feeding.
• 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.
• 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.
• Patients whose QTcF interval exceeded 460 msec on the 12-lead electrocardiogram at screening.

Sponsors & Collaborators

• Takeda: lead

Study Sites (15)

Unknown Facility

Nagoya, Aichi-ken, Japan

Location

Unknown Facility

Fukushima, Fukushima, Japan

Location

Unknown Facility

Maebashi, Gunma, Japan

Location

Unknown Facility

Ohta-shi, Gunma, Japan

Location

Unknown Facility

Sapporo, Hokkaido, Japan

Location

Unknown Facility

Isehara-shi, Kanagawa, Japan

Location

Unknown Facility

Yokohama, Kanagawa, Japan

Location

Unknown Facility

Kumamoto, Kumamoto, Japan

Location

Unknown Facility

Kyoto, Kyoto, Japan

Location

Unknown Facility

Nigata-shi, Niigata, Japan

Location

Unknown Facility

Kurashiki-shi, Okayama-ken, Japan

Location

Unknown Facility

Osaka, Osaka, Japan

Location

Unknown Facility

Suita-shi, Osaka, Japan

Location

Unknown Facility

Kita-adachi-gun, Saitama, Japan

Location

Unknown Facility

Shinjuku-ku, Tokyo, Japan

Location

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

clinicaltrialregistry@tpna.com

+1-877-825-3327

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2012
• First Posted: March 7, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 26, 2015
• Results First Posted: November 26, 2015

Record last verified: 2015-10

Locations

JP (15)