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

22 oktober 2015 bijgewerkt door: Takeda
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

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

167

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Japan
    • Aichi
      • Nagoya-shi, Aichi, Japan
    • Fukushima
      • Fukushima-shi, Fukushima, Japan
    • Gunma
      • Maebashi-shi, Gunma, Japan
      • Ohta-shi, Gunma, Japan
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan
    • Kanagawa
      • Isehara-shi, Kanagawa, Japan
      • Yokohama-shi, Kanagawa, Japan
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japan
    • Kyoto
      • Kyoto-shi, Kyoto, Japan
    • Nigata
      • Nigata-shi, Nigata, Japan
    • Okayama
      • Kurashiki-shi, Okayama, Japan
    • Osaka
      • Osaka-shi, Osaka, Japan
      • Suita-shi, Osaka, Japan
    • Saitama
      • Kita-adachi-gun, Saitama, Japan
    • Tokyo
      • Shinjuku-ku, Tokyo, Japan

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

20 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: TAP-144-SR(6M)
TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 96 weeks.
Geneesmiddel: TAP-144-SR(6M)
Actieve vergelijker: TAP-144-SR(3M)
TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 96 weeks.
Geneesmiddel: TAP-144-SR(3M)

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants With Suppressive Effect of Serum Estradiol (E2) to Menopausal Level (=<30 pg/mL) From Week 4 Through Week 48
Tijdsspanne: Week 4 up to 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Concentration of Serum E2
Tijdsspanne: 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
The measure indicates serum E2 concentration at baseline and post-baseline time points.
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)
Tijdsspanne: 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
This measure indicates serum LH concentration at baseline and post-baseline time points. It was measured in milli-international units per milliliter (mIU/mL).
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)
Tijdsspanne: 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
This measure indicates serum FSH concentration at baseline and post-baseline time points.
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
Tijdsspanne: 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.
Week 96
Distant Disease Free Survival (DDFS) Rate at Week 96
Tijdsspanne: 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.
Week 96
Serum Unchanged TAP-144 Level
Tijdsspanne: 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
This measure indicates the unchanged TAP-144 level in serum.
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
QT Interval Measured by 12-lead Electrocardiogram (ECG)
Tijdsspanne: Baseline, Hour 1, 3, 6 on Day 1, Day 29, 85, 169 and 337
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).
Baseline, Hour 1, 3, 6 on Day 1, Day 29, 85, 169 and 337

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Takeda

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 april 2012

Primaire voltooiing (Werkelijk)

1 december 2014

Studie voltooiing (Werkelijk)

1 december 2014

Studieregistratiedata

Eerst ingediend

28 februari 2012

Eerst ingediend dat voldeed aan de QC-criteria

1 maart 2012

Eerst geplaatst (Schatting)

7 maart 2012

Updates van studierecords

Laatste update geplaatst (Schatting)

26 november 2015

Laatste update ingediend die voldeed aan QC-criteria

22 oktober 2015

Laatst geverifieerd

1 oktober 2015

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • TAP-144-SR(6M)IP/CPH-202
  • JapicCTI-121762 (Register-ID: JapicCTI)
  • U1111-1128-7039 (Register-ID: WHO)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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