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

NCT ID: NCT04236310

Last Updated: 2020-01-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-15
• Study Completion Date: 2022-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHR6390+Anastrozole+Pyrotinib+Trastuzumab±Ovarian Suppression

Group Type: EXPERIMENTAL

SHR6390

Intervention Type: 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

Anastrozole

Intervention Type: DRUG

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

Pyrotinib

Intervention Type: DRUG

Pyrotinib 400mg once daily for 16 weeks

Trastuzumab

Intervention Type: DRUG

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

Interventions

SHR6390

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

Intervention Type: DRUG

Anastrozole

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

Intervention Type: DRUG

Pyrotinib

Pyrotinib 400mg once daily for 16 weeks

Intervention Type: DRUG

Trastuzumab

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Written informed consent for all study according to local regulatory requirements prior to beginning specific protocol procedures.

2. Age at diagnosis ≥18 years and ≤75 years, female.

3. 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.

4. Tumor diameter >2 centimeters with the clinical stage being classified as from IIa to IIIc.

5. ECOG ≤ 1, LVEF ≥ 55%.

6. 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.

Exclusion Criteria

1. Evidence of bilateral invasive breast cancer or metastatic disease (M1).

2. Pevious treatment with chemotherapy, hormonal therapy, an investigational drug for any type of malignancy, or radiation therapy.

3. 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).

4. Known hypersensitivity reaction to one of the compounds or incorporated substances used in this protocol.

5. Active infection or severe symptomatic visceral disease in the last 4 weeks.

6. 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).

7. Prior malignancy with a disease-free survival of < 5 years, except curatively treated basalioma of the skin, pTis of the cervix uteri.

8. Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization) during study treatment.

9. Participation in another clinical trial with any investigational, not marketed drug within 30 days prior to study entry.

10. Not eligible for the trial assessed by the investigators of our study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jiayi Wu, Dr.

Role: CONTACT

pinkscorpio@163.com

0086-21-64370045 ext. 602268

Other Identifiers

RJBC2001

Identifier Type: -

Identifier Source: org_study_id