DAP-Her-01: Study to Evaluate the Efficacy and Safety of SHR6390 Combined With Pyrotinib in HER2+ Advanced Breast Cancer

Sponsor
Henan Cancer Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04293276
Collaborator
Jiangsu HengRui Medicine Co., Ltd. (Industry)
41
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37
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Study Details

Study Description

Brief Summary

The main purpose of this study was to observe the efficacy and safety of treatment with pyrotinib and CDK4/6 inhibitor SHR6390 for HER2-positive metastatic breast cancer.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
41 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Study to Evaluate the Efficacy and Safety of CDK4/6 Inhibitor SHR6390 Combined With Pyrotinib in the Treatment of HER2-positive Advanced Breast Cancer
Actual Study Start Date :
Apr 1, 2020
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment group

Patients with HER2 positive breast cancer will receive Pyrotinib in combination with SHR6390(at protocol defined dose levels) orally until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.

Drug: Pyrotinib
Pyrotinib Tablets

Drug: SHR6390
SHR6390 Tablets

Outcome Measures

Primary Outcome Measures

  1. ORR [From the start of treatment to Disease Progress, assessed up to 2 years]

    ORR by investigator using RECIST Guideline (Version 1.1)

Secondary Outcome Measures

  1. Adverse Events [from the first drug administration to 30 days from the last dose, assessed up to 2 years]

    The number of patients experiencing any adverse events (AE) during the study time

  2. PFS [up to 2 years]

    Progression-Free Survival

  3. OS [up to 2 years]

    Overall Survival

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Local recurrent or metastatic breast cancer suitable for chemotherapy, confirmed histologically.

  • HER2-positive breast cancer(according to 2018 ASCO/CAP HER2 test guideline).

  • Patients with HER2-positive metastatic breast cancer who had received ≤ 1-line treatment in the past;

  • 18-70 years old;

  • ECOG PS 0-1;

  • Life expectancy is not less than 12 weeks;

  • At least one measurable lesion according to RECIST 1.1;

  • ANC ≥ 2.0×109/L, PLT ≥ 100×109/L, Hb ≥ 90 g/L; TBIL≤1.5ULN; ALT and AST≤3×ULN(ALT and AST≤5×ULN if liver metastasis); BUN and Cr≤1.5×ULN;

  • LVEF ≥ 50% and QTc≤470 ms.

Exclusion Criteria:
  • Patients with symptomatic brain metastasis;

  • Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors affecting drug use and absorption;

  • patient who received radiotherapy, chemotherapy, surgery (excluding local puncture) or molecular targeted therapy within 4 weeks before admission; those who received anti-tumor endocrine therapy after screening period;

  • Participated in other drug clinical trials within 4 weeks before admission;

  • Tyrosine kinase inhibitors targeting HER2 (Neratinib, Lapatinib, pyrotinib, etc.) have been used or are being used in the past;

  • Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years;

  • A history of immunodeficiency, including HIV positive, HCV, or other acquired, congenital immunodeficiency disorders, or organ transplantation, is known;

  • Has suffered from any heart disease;

  • Female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial;

  • According to the judgement of the researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of research (including, but not limited to, severe hypertension, severe diabetes, active infections, etc.);

  • Moderate infection occurs within 4 weeks before the first administration (e.g. intravenous drip of antibiotics, antifungal or antiviral drugs according to clinical criteria), fever(> 38.5 ℃) of unknown origin occurs during the screening period/before the first administration;

  • Researchers believe that patients are not suitable for any other situation in this study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Henan Cancer Hospital Zhengzhou Henan China

Sponsors and Collaborators

  • Henan Cancer Hospital
  • Jiangsu HengRui Medicine Co., Ltd.

Investigators

  • Principal Investigator: Min Yan, Professor, Henan Cancer Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Henan Cancer Hospital
ClinicalTrials.gov Identifier:
NCT04293276
Other Study ID Numbers:
  • HR BLTN 014
First Posted:
Mar 3, 2020
Last Update Posted:
Mar 21, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 21, 2022