Treatment of Dalpiciclib Combined With Pyrotinib for Trastuzumab-sensitive HER2+ Advanced Breast Cancer(DAP-Her-02)

NCT05328440 | Unknown Phase 2

• 1 other identifier: MA-BC-II-037
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Based on different HR status, we explored the efficacy and safety of Pyrotinib and Dalpiciclib Isethionate Tablets based combination regimen in the first-line treatment of HER2 + MBC.

Conditions

Breast Neoplasms

Keywords

HER2-positive MBC

Outcome Measures

Primary Outcomes (1)

• PFS (Progression-Free survival)

  From the date into this study (signed ICF) to tumor progression or death.

  up to 2 years

Secondary Outcomes (2)

• ORR (Objective control rate)

  up to 2 years

• Overall survival (OS)

  up to 2 years

Other Outcomes (1)

• Subject safety

  Through study completion,an average of 4 year

Study Arms (2)

Arm A

EXPERIMENTAL

HR-positive/HER2-positive MBC

Drug: Pyrotinib Maleate; Drug: Dalpiciclib Isethionate Tablets; Drug: Fulvestrant

Arm B

EXPERIMENTAL

HR-negative/HER2-positive MBC

Drug: Pyrotinib Maleate; Drug: Dalpiciclib Isethionate Tablets; Drug: Inetetamab

Interventions

Pyrotinib Maleate DRUG

once a day, 125mg each time, taking for 3 weeks, stopping for 1 week, 4 weeks as a cycle. It is recommended to take medicine at about the same time every day, take it with warm water, and fast at least 1 hour before and after taking medicine

Also known as: Pyrotinib

Arm A; Arm B

Dalpiciclib Isethionate Tablets DRUG

400mg once a day, oral administration within 30 minutes after breakfast, continuous administration for 28 days as a cycle

Also known as: SHR6390

Arm A; Arm B

Inetetamab DRUG

the initial dose is 8mg / kg and the subsequent dose is 6mg / kg. It is administered intravenously for 21 days.

Arm B

Fulvestrant DRUG

fluvestrant is administered intravenously on the 1/15 day of the first cycle, and then on the first day of each cycle, 500mg / time, intravenously

Arm A

Eligibility Criteria

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

You may qualify if:

• Premenopausal / perimenopausal / postmenopausal women who aged ≥ 18 years
• Suffering from non resectable locally advanced recurrent breast cancer or metastatic breast cancer
• group A: Women who have breast cancer histopathologically confirmed by positive estrogen receptor (ER; \>10%), positive progesterone receptor (PR; \>1%), and positive human epidermal growth factor receptor 2 (HER2) according to the 2018 American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) human epidermal growth factor receptor 2 (HER2) guideline. The pathological laboratory confirmed that the immunohistochemical (IHC) score was 3 +, or 2 +, and the in situ hybridization (ISH) test was positive (ISH amplification rate ≥ 2.0); (New) the end of trastuzumab treatment in the adjuvant treatment stage \> 12 months, recurrence and metastasis, or no trastuzumab treatment in the early stage; No adjuvant endocrine therapy or postoperative adjuvant endocrine therapy \> 24 months; Premenopausal or perimenopausal patients need to be combined with ofs (OFS includes bilateral ovariectomy or GnRHa drugs); group B: Women who have breast cancer histopathologically confirmed by negative estrogen receptor (ER), negative progesterone receptor (PR; \<1%), and positive human epidermal growth factor receptor 2 (HER2) according to the 2018 American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) human epidermal growth factor receptor 2 (HER2) guideline. The pathological laboratory confirmed that the immunohistochemical (IHC) score was 3 +, or 2 +, and the in situ hybridization (ISH) test was positive (ISH amplification rate ≥ 2.0); (New) the end of trastuzumab treatment in the adjuvant treatment stage \> 12 months, recurrence and metastasis, or no trastuzumab treatment in the early stage;
• No previous systematic treatment for advanced diseases
• at least one measurable lesion or only bone metastasis according to RECIST 1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status 0～1.
• The patient must be able to swallow oral drugs
• The functional level of organs must meet the following requirements:
• a) Bone marrow function i) Absolute neutrophil count（ANC）≥1.5×109/L (no use of growth factor within 14 days) ii) Platelet count（PLT）≥100×109/L (no corrective treatment within 7 days) iii) Hemoglobin level（Hb）≥100 g/L (no corrective treatment within 7 days) b) Liver and kidney function i) Total bilirubin（TBIL）≤1.5 upper limit of normal value (ULN) ii) Alanine transaminase (ALT) and aspartate transaminase (AST) ≤3×ULN iii) Blood urea nitrogen (BUN) and creatinine ≤1.5×ULN and creatinine clearance≥50 mL/min (Cockcroft-Gault formula); c) Color Doppler echocardiography: Left ventricular ejection fraction ≥50% d) 12-lead electrocardiography: QTc interval ≤480 ms
• Volunteers to participate in the study, provision of signed informed consent, good compliance and willingness to cooperate with follow-ups.

You may not qualify if:

• 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;
• Patients previously treated with any CDK4 / 6 inhibitor;
• Those who have other malignant tumors (with the exception of healed cervical carcinoma in situ) occurring in the past 5 years;
• Those who are known to have a history of allergy to the component of study drugs; those who have a history of immunodeficiency, including positive detection of human immunodeficiency virus, hepatitis C virus, active hepatitis B or other acquired, congenital immunodeficiency diseases, or organ transplantation;
• Those who had suffered from any heart disease, including arrhythmia which requires drug treatment or is of clinical significance; myocardial infarction; heart failure; and any other heart disease judged by the investigator as unsuitable for this trial;
• Pregnant and lactating women; fertile women who provide positive results of baseline pregnancy test; women of childbearing age who are unwilling to take effective contraceptive measures during the whole study period;
• If the accompanying diseases (including, but not limited to, severe hypertension, severe diabetes, and active infection, which cannot be controlled by drugs) that would be a potential hazard to participant's health, or affect the completion of the study as per investigator's judgement;
• 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.
• A clear history of neurological or psychiatric disorders, including epilepsy or dementia.
• Researchers believe that patients are not suitable for any other situation in this study.

Sponsors & Collaborators

• Henan Cancer Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pyrotinib; Fulvestrant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Min Yan

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Yan

CONTACT

15713857388; ym200678@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: April 14, 2022
• Study Start: May 20, 2022
• Primary Completion: June 1, 2024
• Study Completion: January 1, 2026
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: five years after publication
• Access Criteria: Please contact Central contact person by Email

Locations

CN (1)