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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 octobre 2015 mis à jour par: 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

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

167

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

20 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: TAP-144-SR(6M)
TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 96 weeks.
Médicament: TAP-144-SR(6M)
Comparateur actif: TAP-144-SR(3M)
TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 96 weeks.
Médicament: TAP-144-SR(3M)

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percentage of Participants With Suppressive Effect of Serum Estradiol (E2) to Menopausal Level (=<30 pg/mL) From Week 4 Through Week 48
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Concentration of Serum E2
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Takeda

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 avril 2012

Achèvement primaire (Réel)

1 décembre 2014

Achèvement de l'étude (Réel)

1 décembre 2014

Dates d'inscription aux études

Première soumission

28 février 2012

Première soumission répondant aux critères de contrôle qualité

1 mars 2012

Première publication (Estimation)

7 mars 2012

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

26 novembre 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

22 octobre 2015

Dernière vérification

1 octobre 2015

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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