A Study of Neoadjuvant SHR6390 in Combination With Anastrozole, Pyrotinib, and Trastuzumab in Patients With ER+/HER2+ Breast Cancer.

NCT04236310 | Unknown Phase 2

• 1 other identifier: RJBC2001
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the efficacy and safety of the SHR6390 in combination with anastrozole, pyrotinib, and trastuzumab in patients with ER-positive, HER2-positive breast cancer in the neoadjuvant setting.

Conditions

Breast Cancer; HER2-positive Breast Cancer; ER-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Ki67 changes from baseline to 2 weeks after the start of the neoadjuvant therapy

  Ki67 changes from baseline to at 2 weeks after the start of the neoadjuvant therapy

  2 weeks

Secondary Outcomes (5)

• Ki67 changes from baseline to at surgery

  average 19 weeks after the start of the neoadjuvant therapy

• Pathological complete response (ypT0/is ypN0) rate

  average 19 weeks after the start of the neoadjuvant therapy

• Objective response rate (ORR)

  average 19 weeks after the start of the neoadjuvant therapy

• Invasive disease-free survival (IDFS)

  5 years

• Tolerability and safety: number of patients whose treatment had to be reduced, delayed or permanently stopped

  during treatment (16 weeks)

Study Arms (1)

SHR6390+Anastrozole+Pyrotinib+Trastuzumab±Ovarian Suppression

EXPERIMENTAL

Drug: SHR6390; Drug: Anastrozole; Drug: Pyrotinib; Drug: Trastuzumab

Interventions

SHR6390 DRUG

SHR6390 150 mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment for 4 cycles

SHR6390+Anastrozole+Pyrotinib+Trastuzumab±Ovarian Suppression

Anastrozole DRUG

Anastrozole 1md, orally once daily for 16 weeks (For premenopausal women, ovarian suppression may be considered)

SHR6390+Anastrozole+Pyrotinib+Trastuzumab±Ovarian Suppression

Pyrotinib DRUG

Pyrotinib 400mg once daily for 16 weeks

SHR6390+Anastrozole+Pyrotinib+Trastuzumab±Ovarian Suppression

Trastuzumab DRUG

Trastuzumab 6mg/kg (loading dose, 8mg/kg), infusion once every 3-week cycle for 5 cycles.

SHR6390+Anastrozole+Pyrotinib+Trastuzumab±Ovarian Suppression

Eligibility Criteria

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

You may qualify if:

• Written informed consent for all study according to local regulatory requirements prior to beginning specific protocol procedures.
• Age at diagnosis ≥18 years and ≤75 years, female.
• Histologically confirmed diagnosis of Unilateral ER+/HER2+ breast cancer. ER-positivity is defined as \>1% stained cells；HER2-positivity is defined as IHC 3+ or if IHC scored 2+, in-situ hybridisation (ISH) suggests amplified HER2 gene.
• Tumor diameter \>2 centimeters with the clinical stage being classified as from IIa to IIIc.
• ECOG ≤ 1, LVEF ≥ 55%.
• Laboratory requirements: for hematology, absolute neutrophil count (ANC) ≥1.5 × 109 / L and platelets ≥100 × 109 / L and hemoglobin ≥90 g/L; for hepatic function, total bilirubin ≤1.5 × UNL, AST and ALT ≤2.5 × UNL; for renal function, SCr ≤1.5 × UNL.

You may not qualify if:

• Evidence of bilateral invasive breast cancer or metastatic disease (M1).
• Pevious treatment with chemotherapy, hormonal therapy, an investigational drug for any type of malignancy, or radiation therapy.
• Any of the following exist in the last 6 months: known or suspected congestive heart failure (≥ NYHA II), persistent arrhythmias (≥ grade 2), atrial fibrillation of any grade, coronary / peripheral bypass, symptomatic congestive heart failure, cerebrovascular accidents (including transient cerebral hemorrhage attacks or symptomatic pulmonary embolism).
• Known hypersensitivity reaction to one of the compounds or incorporated substances used in this protocol.
• Active infection or severe symptomatic visceral disease in the last 4 weeks.
• Patients with HIV infection or known AIDS, or patients with infection of active hepatitis B (HBV DNA ≥1000IU / ml) or hepatitis C (hepatitis C antibody is positive and HCV RNA is above the lower limit of detection of the analytical method).
• Prior malignancy with a disease-free survival of \< 5 years, except curatively treated basalioma of the skin, pTis of the cervix uteri.
• Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization) during study treatment.
• Participation in another clinical trial with any investigational, not marketed drug within 30 days prior to study entry.
• Not eligible for the trial assessed by the investigators of our study.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Anastrozole; pyrotinib; Trastuzumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Jiayi Wu, Dr.

CONTACT

0086-21-64370045; pinkscorpio@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: January 22, 2020
• Study Start: January 15, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share