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Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy for HR +/HER2 + Advanced Breast Cancer

Sponsor
Peking University Cancer Hospital & Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05577442
Collaborator
(none)
52
Enrollment
1
Arm
24
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study investigates the efficacy and safety of trastuzumab, pyrotinib combined with dalpiciclib and endocrine therapy for patients with advanced HR+/HER2+ brest cancer, providing more possible effective regimens for the survival benefit of these patients in clinical practice.

Condition or Disease Intervention/Treatment Phase
  • Drug: Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy
 Phase 2

Detailed Description

This study is a single-arm, open-label, multicenter, phase II clinical study. Subjects were eligible for screening and entered the trial period after enrollment and received treatment with pyrotinib（320mg/day), trastuzumab(8 mg→6mg/every 3 week), dalpiciclib(125mg once daily for 3 weeks, followed by 1 week off in each 4-week cycle), endocrine therapy until disease progression, or intolerable toxicity, or withdrawal of informed consent, or discontinuation of medication at the investigator 's discretion. On-study imaging assessments were performed according to RECIST 1.1 criteria and the site assessment was final.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
52 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Peking University Cancer Hospital & Institute
Anticipated Study Start Date :
Oct 20, 2022
Anticipated Primary Completion Date :
Oct 20, 2023
Anticipated Study Completion Date :
Oct 20, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy

for the HR+/HER2+MBC will be treated with Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy. Endocrine drug be determined by physician depend on the history.

Drug: Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy
Trastuzumab (8-6mg/3weekly)，Pyrotinib（320mg/day）Dalpiciclib（125mg/day，With three weeks separated by one week）
Other Names:
  • Trastuzumab Pyrotinib Dalpiciclib

    		•

    Outcome Measures

    Primary Outcome Measures

    1. ORR [8week]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Female breast cancer patients of any menopausal status aged 18-75 years.

    2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.

    3. Female breast cancer patients with HER2-positive HR-positive of recurrence or metastasis and are not suitable for surgical resection or radiation therapy with the purpose of cure.

    4. ER and/or PR +: defined as positively stained tumor cells representing ≥ 10% of all tumor cells (confirmed by investigator review at the site) and HER2 +: defined as IHC 3 + or IHC 2 + and FISH +/CISH +.

    5. measurable lesions by RECIST 1.1 criteria.

    6. Patients' previous treatment should meet: a) prior systemic (neo) adjuvant therapy is allowed but not required, and if received, the disease-free interval (DFI) must be > 24 months (DFI is defined as the time from surgery to the first recurrence); b) ≤ 1 line of systemic therapy for the tumor (including anti-HER2 targeted therapy, endocrine therapy and chemotherapy) is received at the metastatic stage;

    7. Stable patients with brain metastases are allowed.

    8. life expectancy ≥ 12 weeks.

    9. adequate organ and bone marrow function.

    10. adequate cardiac reserve, left ventricular ejection fraction (LVEF) ≥ 45% on echocardiogram.

    Exclusion Criteria:

    1. patients who are not suitable for endocrine therapy as judged by the investigator. Including symptomatic, advanced patients with disseminated visceral disease who are at short-term risk of life-threatening complications (including patients with uncontrolled large exudates [pleural, pericardial, abdominal], pulmonary lymphangitis and more than 50% hepatic involvement).

    2. previous treatment with CDK4/6 inhibitors.

    3. previous treatment with TKI.

    4. visceral crisis.

    5. Major surgery, chemotherapy, radiation therapy, any investigational agent, or other anticancer therapy within 2 weeks before entering the study.

    6. Have been diagnosed with any other malignancy within 3 years before entering the study, except for curatively treated non-melanoma skin cancer, basal cell or squamous cell skin cancer, or cervical carcinoma in situ.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Peking University Cancer Hospital & Institute

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Li Huiping, Head of the department of breast oncology, Peking University Cancer Hospital & Institute
    ClinicalTrials.gov Identifier:
    NCT05577442
    Other Study ID Numbers:
    • OBU-BC-Ⅱ-077
    First Posted:
    Oct 13, 2022
    Last Update Posted:
    Oct 19, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms
    Trastuzumab

    Study Results

    No Results Posted as of Oct 19, 2022