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PAlbociclib Plus Tamoxifen for the Treatment of Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Women - Asian studY

NCT03423199

Description:

This study is conducted to evaluate the benefit of adding palbociclib in hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer patients, regardless of menopausal status, treated with tamoxifen (with or without goserelin) versus tamoxifen alone (with or without goserelin).

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: PAlbociclib Plus Tamoxifen for the Treatment of Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Women - Asian studY
  • Official Title: Asian, International, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Tamoxifen With or Without Palbociclib ± Goserelin in Women With Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: NCCH1607
  • SECONDARY ID: WI217662
  • NCT ID: NCT03423199

Conditions

  • Breast Neoplasms

Interventions

DrugSynonymsArms
PalbociclibPD-0332991Palbociclib + Tamoxifen ± Goserelin
PlaceboPlacebo + Tamoxifen ± Goserelin
TamoxifenPalbociclib + Tamoxifen ± Goserelin
GoserelinPalbociclib + Tamoxifen ± Goserelin

Purpose

This study is conducted to evaluate the benefit of adding palbociclib in hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer patients, regardless of menopausal status, treated with tamoxifen (with or without goserelin) versus tamoxifen alone (with or without goserelin).

Trial Arms

NameTypeDescriptionInterventions
Palbociclib + Tamoxifen ± GoserelinExperimentalPalbociclib 125 mg/day, orally once daily on Day 1 to Day 21 followed by 7 days off treatment for each 28 day cycle, plus tamoxifen 20 mg orally once daily (continuously)
  • Palbociclib
  • Tamoxifen
  • Goserelin
Placebo + Tamoxifen ± GoserelinActive ComparatorPlacebo orally once daily on Day 1 to Day 21 followed by 7 days off treatment for each 28 day cycle, plus tamoxifen 20 mg orally once daily (continuously)
  • Placebo
  • Tamoxifen
  • Goserelin

Eligibility Criteria

        Inclusion Criteria:

          -  Women 18 years of age or older with histologically or cytologically proven locally
             advanced or metastatic breast cancer, not amenable to resection or radiation therapy
             with curative intent

          -  Documented diagnosis of HR+/HER2- breast cancer

          -  Any menopausal status

          -  Previously untreated with any endocrine therapy for their HR+/HER2- advanced breast
             cancer; or progressed while on or within 3 month from prior endocrine therapy other
             than tamoxifen for advanced breast cancer. If patients have adjuvant endocrine
             therapy, they must satisfy as follows: progressed 12 months or more since prior
             adjuvant endocrine therapy with tamoxifen; or progressed during or after adjuvant
             endocrine therapy with an aromatase inhibitor.

          -  Measurable disease or non-measurable disease as defined by RECIST ver.1.1

          -  Eastern Cooperative Oncology Group (ECOG) PS 0-1

          -  Adequate organ and marrow function, resolution of all toxic effects of prior therapy
             or surgical procedures

        Exclusion Criteria:

          -  Prior treatment with any CDK inhibitor, tamoxifen, everolimus, or agent that inhibits
             the PI3K-mTOR pathway

          -  Patients with extensive advanced/metastatic, symptomatic visceral disease, or known
             uncontrolled or symptomatic CNS metastases

          -  Use of strong or moderate CYP3A4 and/or CYP2D6 inhibitors or inducers

          -  Major surgery or any anti-cancer therapy within 2 weeks of randomization

          -  Prior stem cell or bone marrow transplantation
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression-free survival (PFS)
Time Frame:Baseline up to 3.5 years
Safety Issue:
Description:The time from the date of randomization to the date of the first documentation of objective progression of disease (PD), clinically diagnosed symptomatic deterioration, or death due to any cause in the absence of documented PD, whichever occurs first.

Secondary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:From the randomization of the last patient up to 3 years
Safety Issue:
Description:The time from date of randomization to date of death due to any cause.
Measure:Survival Probabilities at 1 year, 2 year, and 3 year
Time Frame:From the randomization of the last patient up to 3 years
Safety Issue:
Description:The probability of survival 1 year, 2 or 3 years after the date of randomization based on the Kaplan-Meier estimate.
Measure:Objective Response (OR)
Time Frame:Baseline up to 3.5 years
Safety Issue:
Description:Complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumors (RECIST) ver.1.1 recorded from randomization until disease progression or death due to any cause.
Measure:Duration of Response (DR)
Time Frame:Baseline up to 3.5 years
Safety Issue:
Description:The time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first.
Measure:Clinical Benefit Response (CBR)
Time Frame:Baseline up to 3.5 years
Safety Issue:
Description:CR or PR or SD >=24 weeks according to the RECIST version 1.1 recorded in the time period between randomization and disease progression or death of any cause.
Measure:Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scale Scores
Time Frame:Baseline up to 3.5 years
Safety Issue:
Description:The EORTC-QLQ-C30 is a 30-item questionnaire composed of five multi-item functional subscales (physical, role, emotional, cognitive , and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global quality of life (QOL) subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The questionnaire employs 28 4-point Likert scales with responses from "not at all" to "very much" and two 7-point Likert scales for global health and overall QOL. Responses to all items are then converted to a 0 to 100 scale. For functional and global QOL scales, higher scores represent a better level of functioning/QOL. For symptom-oriented scales, a higher score represents more severe symptoms. A 10-point or higher change in scores from baseline is considered clinically significant.
Measure:Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Breast Cancer Module (EORTC QLQ BR23) Functional Scale Scores
Time Frame:Baseline up to 3.5 years
Safety Issue:
Description:The EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and four symptom scales (systemic side effects, breast symptoms, arm symptoms, upset by hair loss). QLQ-BR23 questionnaire employs 4-point scales with responses from 'not at all' to 'very much'. All scores are converted to a 0 to 100 scale. For functional scales, higher scores represent a better level of functioning.
Measure:Trough plasma concentrations of palbociclib
Time Frame:Cycle 1/Day 15 and Cycle 2/Day 15
Safety Issue:
Description:Ctrough for palbociclib
Measure:Trough plasma concentrations of tamoxifen, 4-hydroxytamoxifen, N-desmethyltamoxifen and endoxifen
Time Frame:Cycle 2/Day 15 and Cycle 3/Day 15
Safety Issue:
Description:Ctrough for tamoxifen, 4-hydroxytamoxifen, N-desmethyltamoxifen and endoxifen
Measure:Treatment-Emergent Adverse Events
Time Frame:From the first dose of the investigational product until 28 days after the last dose of study drugs
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:National Cancer Center, Japan

Trial Keywords

  • breast Cancer
  • palbociclib (PD-0332991)
  • tamoxifen
  • goserelin
  • any menopausal status
  • hormone receptor positive
  • HER2 negative
  • locally advanced
  • metastatic

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