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

NCT05577442 | Unknown Phase 2 DMC

• 1 other identifier: OBU-BC-Ⅱ-077
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Neoplasm Female

Outcome Measures

Primary Outcomes (1)

• ORR

  8week

Study Arms (1)

Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy

EXPERIMENTAL

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

Interventions

Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy DRUG

Trastuzumab (8-6mg/3weekly)，Pyrotinib（320mg/day）Dalpiciclib（125mg/day，With three weeks separated by one week）

Also known as: Trastuzumab Pyrotinib Dalpiciclib

Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female breast cancer patients of any menopausal status aged 18-75 years.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
• 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.
• 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 +.
• measurable lesions by RECIST 1.1 criteria.
• 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;
• Stable patients with brain metastases are allowed.
• life expectancy ≥ 12 weeks.
• adequate organ and bone marrow function.
• adequate cardiac reserve, left ventricular ejection fraction (LVEF) ≥ 45% on echocardiogram.

You may not qualify if:

• 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).
• previous treatment with CDK4/6 inhibitors.
• previous treatment with TKI.
• visceral crisis.
• Major surgery, chemotherapy, radiation therapy, any investigational agent, or other anticancer therapy within 2 weeks before entering the study.
• 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.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

MeSH Terms

Interventions

Trastuzumab; dalpiciclib

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

GUOHONG SONG

CONTACT

13911263305; songguohong918@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the department of breast oncology

Study Record Dates

• First Submitted: October 9, 2022
• First Posted: October 13, 2022
• Study Start: October 20, 2022
• Primary Completion: October 20, 2023
• Study Completion: October 20, 2024
• Last Updated: October 19, 2022

Record last verified: 2022-10