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

National Cancer Center, Japan

Status and phase: Active, not recruiting; Phase 3

Conditions: Breast Neoplasms

Treatments: Drug: Tamoxifen; Drug: Placebo; Drug: Goserelin; Drug: Palbociclib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03423199

WI217662 (Other Identifier)

NCCH1607

Details and patient eligibility

About

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).

Enrollment: 180 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 2 patient groups

Palbociclib + Tamoxifen ± Goserelin

Experimental group

Description:

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)

Treatment:

Drug: Palbociclib

Drug: Goserelin

Drug: Tamoxifen

Placebo + Tamoxifen ± Goserelin

Active Comparator group

Description:

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)

Treatment:

Drug: Goserelin

Drug: Placebo

Drug: Tamoxifen