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Premenopausal Breast CancerPhase 3NCT01546649

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

A Phase 3 study testing TAP-144-SR(6M) and TAP-144-SR(3M) in people with Premenopausal Breast Cancer, run by Takeda at 15 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 20 years and older, women only
Conditions the study is for
Premenopausal Breast Cancer
What is being tested?
TAP-144-SR(6M) and TAP-144-SR(3M)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
167 participants
Where
15 sitesJapan
Study dates
Apr 2012to Dec 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.)
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Japan15 sites

  • Study site

    Fukushima, Fukushima

  • Study site

    Isehara-shi, Kanagawa

  • Study site

    Kita-adachi-gun, Saitama

  • Study site

    Kumamoto, Kumamoto

  • Study site

    Kurashiki-shi, Okayama-ken

  • Study site

    Kyoto, Kyoto

  • Study site

    Maebashi, Gunma

  • Study site

    Nagoya, Aichi-ken

  • Study site

    Nigata-shi, Niigata

  • Study site

    Ohta-shi, Gunma

  • Study site

    Osaka, Osaka

  • Study site

    Sapporo, Hokkaido

  • Study site

    Shinjuku-ku, Tokyo

  • Study site

    Suita-shi, Osaka

  • Study site

    Yokohama, Kanagawa

Other trials in Japan

About this study

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

Being tested
TAP-144-SR(6M), TAP-144-SR(3M)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAP-144-SR(6M)Drug

  • TAP-144-SR(3M)Drug

Study groups in NCT01546649
Study groupRoleWhat they receive
TAP-144-SR(6M)ExperimentalTAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 96 weeks.
Receives: Drug: TAP-144-SR(6M)
TAP-144-SR(3M)Active comparatorTAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 96 weeks.
Receives: Drug: TAP-144-SR(3M)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 4 up to Week 48

Secondary outcomes (7)

  1. Concentration of Serum E2

    The measure indicates serum E2 concentration at baseline and post-baseline time points.

    Measured: 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

  2. Concentration of Serum Luteinizing Hormone (LH)

    This measure indicates serum LH concentration at baseline and post-baseline time points. It was measured in milli-international units per milliliter (mIU/mL).

    Measured: 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

  3. Concentration of Follicle Stimulating Hormone (FSH)

    This measure indicates serum FSH concentration at baseline and post-baseline time points.

    Measured: 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

  4. Disease Free Survival (DFS) Rate at Week 96

    DFS is defined as time from randomization to earliest day of onset the events, recurrence [including recurrence in the ipsilateral breast], secondary cancer [including breast cancer in the contralateral breast] and death. DFS at Week 96 was defined as the percentage, calculated with Kaplan-Meier method, of participants did not experience any events at Week 96 since the randomization.

    Measured: Week 96

  5. Distant Disease Free Survival (DDFS) Rate at Week 96

    DDFS is defined as time from randomization to earliest day of onset the events, distant recurrence, secondary cancer [including breast cancer in the contralateral breast] and death. DDFS at week 96 was defined as the percentage calculated with Kaplan-Meier method, of participants did not experience any events at week 96 since the randomization.

    Measured: Week 96

  6. Serum Unchanged TAP-144 Level

    This measure indicates the unchanged TAP-144 level in serum.

    Measured: 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 and 337

  7. QT Interval Measured by 12-lead Electrocardiogram (ECG)

    12-lead electrocardiography measurement was performed in supine position after 5 minutes at rest. Each measurement was recorded continuously for 10 seconds at the recording speed of 25 millimeter/second (mm/second).

    Measured: Baseline, Hour 1, 3, 6 on Day 1, Day 29, 85, 169 and 337

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
167 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01546649
Sponsor's protocol ID
TAP-144-SR(6M)IP/CPH-202
Other IDs
JapicCTI-121762, U1111-1128-7039
Status last verified
Oct 2015
First submitted
28 Feb 2012
Last updated
26 Nov 2015

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TAP-144-SR(6M) and TAP-144-SR(3M) in people with Premenopausal Breast Cancer, run by Takeda at 15 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Suppressive Effect of Serum Estradiol (E2) to Menopausal Level (=<30 pg/mL) From Week 4 Through Week 48 (time frame: Week 4 up to Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01546649.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2015.

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