PAlbociclib Plus Tamoxifen for the Treatment of Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Women - Asian studY (PATHWAY)
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| ClinicalTrials.gov Identifier: NCT03423199 |
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Recruitment Status :
Active, not recruiting
First Posted : February 6, 2018
Last Update Posted : April 6, 2022
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Sponsor:
National Cancer Center, Japan
Collaborators:
Pfizer
Korean Cancer Study Group
Information provided by (Responsible Party):
National Cancer Center, Japan
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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Neoplasms | Drug: Palbociclib Drug: Placebo Drug: Tamoxifen Drug: Goserelin | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 180 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | February 9, 2018 |
| Estimated Primary Completion Date : | July 2022 |
| Estimated Study Completion Date : | July 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Breast cancer
| Arm | Intervention/treatment |
|---|---|
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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)
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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: 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 |
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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)
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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 |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03423199
Locations
Show 23 study locations
Sponsors and Collaborators
National Cancer Center, Japan
Pfizer
Korean Cancer Study Group
Investigators
| Study Chair: | Kan Yonemori, MD, PhD | Department of Breast and Medical Oncology, National Cancer Center Hospital |
| Responsible Party: | National Cancer Center, Japan |
| ClinicalTrials.gov Identifier: | NCT03423199 |
| Other Study ID Numbers: |
NCCH1607 WI217662 ( Other Identifier: Pfizer ) |
| First Posted: | February 6, 2018 Key Record Dates |
| Last Update Posted: | April 6, 2022 |
| Last Verified: | April 2022 |
| 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 |
Keywords provided by National Cancer Center, Japan:
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breast Cancer palbociclib (PD-0332991) tamoxifen goserelin any menopausal status |
hormone receptor positive HER2 negative locally advanced metastatic |
Additional relevant MeSH terms:
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Tamoxifen Goserelin Palbociclib Estrogen Antagonists Hormone Antagonists |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Bone Density Conservation Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |