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

N

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

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

Trial contacts and locations

23

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Data sourced from clinicaltrials.gov

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