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Status unknownNCT04246502Updated Feb 5, 2020

Capecitabine Plus Pyrotinib Versus Capecitabine Plus Trastuzumab and Pertuzumab in the First-line Treatment of HER2-positive Metastatic Breast Cancer

A Phase 2 interventional study of Capecitabine and Pyrotinib and Capecitabine,Trastuzumab, and Pertuzumab in Metastatic Breast Cancer, sponsored by Shandong Cancer Hospital and Institute. Status unknown. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-02-05.

Sponsored by Shandong Cancer Hospital and Institute · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
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Study summary

This is a randomized, multicenter phase 2 clinical trial to evaluate the efficacy and safety of capecitabine plus pyrotinib versus capecitabine plus trastuzumab plus pertuzumab in patients who have HER2 positive metastatic breast cancer and have not received systemic anticancer therapy for advanced disease.

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Conditions studied

  • Metastatic Breast Cancer

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03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 200 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Shandong Cancer Hospital and Institute is the lead sponsor of 103 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    A

    Drug: Capecitabine and Pyrotinib

  • Active comparator
    B

    Drug: Capecitabine,Trastuzumab, and Pertuzumab

Interventions

  • DrugCapecitabine and Pyrotinib

    Pyrotinib 400mg orally daily until progressive disease

  • DrugCapecitabine,Trastuzumab, and Pertuzumab

    as instruction

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What researchers measure

Primary outcomes

  1. Progression Free Survival

    Time frame: Approximately 42 months

Secondary outcomes

  1. Adverse Events and Serious Adverse Events

    AEs+SAEs

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

  2. Overall Survival

    Time frame: Up to 2 years

  3. Objective Response Rate

    Time frame: Approximately 42 months

  4. Duration of Objective Response

    Time frame: Approximately 42 months

  5. Clinical Benefit rate

    Time frame: From the start of randomization to 6 months

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04246502
Lead sponsor
Shandong Cancer Hospital and Institute
Responsible party
Zhiyong Yu (Shandong Breast Disease Centre, Shandong Cancer Hospital and Institute) — Principal investigator
First posted
Jan 29, 2020
Start date
Jan 2020 (estimated)
Primary completion
Dec 2022 (estimated)
Completion
Dec 2024 (estimated)
Last update
Feb 5, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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