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

NCT03423199 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: NCCH1607WI217662
• Study Type: interventional
• Target: 180
• Locations: 4 countries
• Sites: 23

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).

Conditions

Breast Neoplasms

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  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.

  Baseline up to 3.5 years

Secondary Outcomes (10)

• Overall Survival (OS)

  From the randomization of the last patient up to 3 years

• Survival Probabilities at 1 year, 2 year, and 3 year

  From the randomization of the last patient up to 3 years

• Objective Response (OR)

  Baseline up to 3.5 years

• Duration of Response (DR)

  Baseline up to 3.5 years

• Clinical Benefit Response (CBR)

  Baseline up to 3.5 years

Study Arms (2)

Palbociclib + Tamoxifen ± Goserelin

EXPERIMENTAL

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)

Drug: Palbociclib; Drug: Tamoxifen; Drug: Goserelin

Placebo + Tamoxifen ± Goserelin

ACTIVE COMPARATOR

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)

Drug: Placebo; Drug: Tamoxifen; Drug: Goserelin

Interventions

Palbociclib DRUG

Palbociclib, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment

Also known as: PD-0332991

Palbociclib + Tamoxifen ± Goserelin

Placebo DRUG

Placebo, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment

Placebo + Tamoxifen ± Goserelin

Tamoxifen DRUG

Tamoxifen, 20mg, orally once daily (continuously)

Palbociclib + Tamoxifen ± Goserelin; Placebo + Tamoxifen ± Goserelin

Goserelin DRUG

For pre/perimenopausal patients only: Goserelin, 3.6 mg, subcutaneously every 4 weeks; or 10.8 mg, subcutaneously every 12 weeks

Palbociclib + Tamoxifen ± Goserelin; Placebo + Tamoxifen ± Goserelin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Japan: lead
• Pfizer: collaborator
• Korean Cancer Study Group: collaborator

Study Sites (23)

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, 464-8681, Japan

Location

National Cancer Center Hospital East

Kashiwa, Chiba, 2778577, Japan

Location

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, 7910280, Japan

Location

National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido, 0030804, Japan

Location

Hyogo Cancer Center

Akashi, Hyōgo, 6738558, Japan

Location

Kanagawa Cancer Center

Yokohama, Kanagawa, 2418515, Japan

Location

Kindai University Hospital

Ōsaka-sayama, Osaka, 5898511, Japan

Location

Toranomon Hospital

Minato-Ku, Tokyo, 1058470, Japan

Location

Chiba Cancer Center

Chiba, 2608717, Japan

Location

Kyusyu Cancer Center

Fukuoka, 8111395, Japan

Location

National Hospital Organization Osaka National Hospital

Osaka, 5400006, Japan

Location

National Cancer Center Hospital

Tokyo, 104-0045, Japan

Location

National University Hospital

Singapore, 119882, Singapore

Location

National Cancer Centre Singapore

Singapore, 169610, Singapore

Location

National Cancer Center

Gyeonggi-do, 10408, South Korea

Location

Ajou University Hospital

Gyeonggi-do, 16499, South Korea

Location

Seoul National University Bundang Hospital

Gyeonggi-do, 463-707, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Severance Hospital, Yonsei University Health System

Soeul, 03722, South Korea

Location

National Taiwan University Hospital

Taipei, 10048, Taiwan

Location

Taipei Vetarans General Hospital

Taipei, 11217, Taiwan

Location

Sun Yat-Sen Cancer Center

Taipei, 11259, Taiwan

Location

Related Publications (1)

• Noguchi E, Yamanaka T, Mukai H, Yamamoto N, Chung CF, Lu YS, Chang DY, Sohn J, Kim GM, Lee KH, Lee SC, Iwasa T, Iwata H, Watanabe K, Jung KH, Tanabe Y, Kang SY, Yasojima H, Aogi K, Tokunaga E, Sim SH, Yap YS, Matsumoto K, Tseng LM, Umeyama Y, Sudo K, Kojima Y, Hata T, Kuchiba A, Shibata T, Nakamura K, Fujiwara Y, Tamura K, Yonemori K. A phase 3 study (PATHWAY) of palbociclib plus tamoxifen in patients with HR-positive/HER2-negative advanced breast cancer. NPJ Breast Cancer. 2024 Aug 22;10(1):76. doi: 10.1038/s41523-024-00684-w.

  PMID: 39174547 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

palbociclib; Tamoxifen; Goserelin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Kan Yonemori, MD, PhD

  Department of Breast and Medical Oncology, National Cancer Center Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: February 6, 2018
• Study Start: February 9, 2018
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: March 22, 2024

Record last verified: 2024-03

Locations

SG (2); TW (3); JP (12); KR (6)