NCT03863223

Brief Summary

This is a randomized, double-blinded, multicenter phase 3 clinical trial to evaluate the efficacy and safety of pyrotinib plus trastuzumab plus docetaxel versus placebo plus trastuzumab plus docetaxel in patients who have HER2 positive metastatic breast cancer and have not received systemic anticancer therapy for advanced disease.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
590

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2019

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

April 22, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

November 23, 2022

Status Verified

November 1, 2022

Enrollment Period

3.7 years

First QC Date

March 1, 2019

Last Update Submit

November 21, 2022

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • PFS

    Progression Free Survival

    Approximately 42 months

Secondary Outcomes (5)

  • AEs+SAEs

    From the first drug administration to within 28 days for the last treatment

  • OS

    Up to 2 years

  • ORR

    Approximately 42 months

  • DoR

    Approximately 42 months

  • CBR

    From the start of randomization to 6 months

Study Arms (2)

A

EXPERIMENTAL

Pyrotinib Plus trastuzumab and docetaxel

Drug: Pyrotinib, Trastuzumab, Docetaxel

B

PLACEBO COMPARATOR

Placebo plus trastuzumab and docetaxel

Drug: Placebo, Trastuzumab, Docetaxel

Interventions

Pyrotinib, Trastuzumab, DocetaxelDRUG

Pyrotinib 400mg orally daily until progressive disease

A
Placebo, Trastuzumab, DocetaxelDRUG

Placebo 400mg orally daily until progressive disease

B

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HER2 positive recurrent or metastasis breast cancer.
  • Patients with measurable disease are eligible.
  • Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1.
  • Adequate organ function.
  • Signed, written inform consent obtained prior to any study procedure.

You may not qualify if:

  • History of anti-cancer therapy for MBC（with the exception of one prior hormonal regimen for MBC）.
  • History of HER tyrosine kinase inhibitors or monoclonal antibody for breast cancer in any treatment setting，except trastuzumab used in the neo-adjuvant or adjuvant setting.
  • Assessed by the investigator to be unable receive systemic chemotherapy.
  • History of other malignancy within the last 5 years，except for carcinoma in situ of cervix，basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent.
  • Pregnant or lactating women，or for women of childbearing potential unwilling to use a highly-effective contraception during of the study treatment and for at least 7 months after the last dose of study treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Institute and Hospital,Chinese Academy of Medical Science

Beijing, Beijing Municipality, China

Location

Related Publications (1)

  • Ma F, Yan M, Li W, Ouyang Q, Tong Z, Teng Y, Wang Y, Wang S, Geng C, Luo T, Zhong J, Zhang Q, Liu Q, Zeng X, Sun T, Mo Q, Liu H, Cheng Y, Cheng J, Wang X, Nie J, Yang J, Wu X, Wang X, Li H, Ye C, Dong F, Wu S, Zhu X, Xu B; PHILA Investigators. Pyrotinib versus placebo in combination with trastuzumab and docetaxel as first line treatment in patients with HER2 positive metastatic breast cancer (PHILA): randomised, double blind, multicentre, phase 3 trial. BMJ. 2023 Oct 31;383:e076065. doi: 10.1136/bmj-2023-076065.

    PMID: 37907210DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pyrotinibTrastuzumabDocetaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

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
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2019

First Posted

March 5, 2019

Study Start

April 22, 2019

Primary Completion

December 30, 2022

Study Completion

July 30, 2024

Last Updated

November 23, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)