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Trial record 1 of 1 for:    NCT03423199
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PAlbociclib Plus Tamoxifen for the Treatment of Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Women - Asian studY (PATHWAY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03423199
Recruitment Status : Active, not recruiting
First Posted : February 6, 2018
Last Update Posted : November 19, 2020
Sponsor:
Collaborators:
Pfizer
Korean Cancer Study Group
Information provided by (Responsible Party):
National Cancer Center, Japan

Tracking Information
First Submitted Date  ICMJE January 9, 2018
First Posted Date  ICMJE February 6, 2018
Last Update Posted Date November 19, 2020
Actual Study Start Date  ICMJE February 9, 2018
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2018)
Progression-free survival (PFS) [ Time Frame: Baseline up to 3.5 years ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2018)
  • Overall Survival (OS) [ Time Frame: From the randomization of the last patient up to 3 years ]
    The time from date of randomization to date of death due to any cause.
  • Survival Probabilities at 1 year, 2 year, and 3 year [ Time Frame: From the randomization of the last patient up to 3 years ]
    The probability of survival 1 year, 2 or 3 years after the date of randomization based on the Kaplan-Meier estimate.
  • Objective Response (OR) [ Time Frame: Baseline up to 3.5 years ]
    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.
  • Duration of Response (DR) [ Time Frame: Baseline up to 3.5 years ]
    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.
  • Clinical Benefit Response (CBR) [ Time Frame: Baseline up to 3.5 years ]
    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.
  • 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 ]
    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.
  • 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 ]
    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.
  • Trough plasma concentrations of palbociclib [ Time Frame: Cycle 1/Day 15 and Cycle 2/Day 15 ]
    Ctrough for palbociclib
  • Trough plasma concentrations of tamoxifen, 4-hydroxytamoxifen, N-desmethyltamoxifen and endoxifen [ Time Frame: Cycle 2/Day 15 and Cycle 3/Day 15 ]
    Ctrough for tamoxifen, 4-hydroxytamoxifen, N-desmethyltamoxifen and endoxifen
  • Treatment-Emergent Adverse Events [ Time Frame: From the first dose of the investigational product until 28 days after the last dose of study drugs ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PAlbociclib Plus Tamoxifen for the Treatment of Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Women - Asian studY
Official Title  ICMJE 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
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE
  • Drug: Palbociclib
    Palbociclib, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
    Other Name: PD-0332991
  • Drug: Placebo
    Placebo, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
  • Drug: Tamoxifen
    Tamoxifen, 20mg, orally once daily (continuously)
  • Drug: Goserelin
    For pre/perimenopausal patients only: Goserelin, 3.6 mg, subcutaneously every 4 weeks; or 10.8 mg, subcutaneously every 12 weeks
Study Arms  ICMJE
  • Experimental: Palbociclib + Tamoxifen ± Goserelin
    Palbociclib 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)
    Interventions:
    • Drug: Palbociclib
    • Drug: Tamoxifen
    • Drug: Goserelin
  • Active Comparator: Placebo + Tamoxifen ± Goserelin
    Placebo 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)
    Interventions:
    • Drug: Placebo
    • Drug: Tamoxifen
    • Drug: Goserelin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 3, 2018)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan,   Korea, Republic of,   Singapore,   Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03423199
Other Study ID Numbers  ICMJE NCCH1607
WI217662 ( Other Identifier: Pfizer )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Center, Japan
Study Sponsor  ICMJE National Cancer Center, Japan
Collaborators  ICMJE
  • Pfizer
  • Korean Cancer Study Group
Investigators  ICMJE
Study Chair: Kan Yonemori, MD, PhD Department of Breast and Medical Oncology, National Cancer Center Hospital
PRS Account National Cancer Center, Japan
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP