Back to results

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

Primary Purpose

Breast Cancer, HER2-positive Breast Cancer, ER-positive Breast Cancer

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

SHR6390

Anastrozole

Pyrotinib

Trastuzumab

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SHR6390+Anastrozole+Pyrotinib+Trastuzumab±Ovarian Suppression

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Ki67 changes from baseline to at surgery

Pathological complete response (ypT0/is ypN0) rate

Absence of invasive cancer in the breast and axillary nodes, irrespective of ductal carcinoma in situ.

Objective response rate (ORR)

ORR includes all patients whose cancer has a partial or complete response according to RECIST 1.1

Invasive disease-free survival (IDFS)

IDFS is defined as the time period between registration and first event (ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, second primary nonbreast invasive cancer)

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

Descriptive statistics will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped.

Full Information

NCT ID

NCT04236310

First Posted

January 17, 2020

Last Updated

January 17, 2020

Sponsor

Ruijin Hospital

Collaborators

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04236310

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Unknown status

Study Start Date

January 15, 2020 (Anticipated)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ruijin Hospital

Collaborators

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, HER2-positive Breast Cancer, ER-positive Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

37 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SHR6390+Anastrozole+Pyrotinib+Trastuzumab±Ovarian Suppression

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

SHR6390

Intervention Description

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

Intervention Name(s)

Anastrozole

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Pyrotinib

Intervention Description

Pyrotinib 400mg once daily for 16 weeks

Intervention Type

Drug

Intervention Name(s)

Trastuzumab

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

Ki67 changes from baseline to at surgery

Description

Ki67 changes from baseline to at surgery

Time Frame

average 19 weeks after the start of the neoadjuvant therapy

Title

Pathological complete response (ypT0/is ypN0) rate

Description

Absence of invasive cancer in the breast and axillary nodes, irrespective of ductal carcinoma in situ.

Time Frame

average 19 weeks after the start of the neoadjuvant therapy

Title

Objective response rate (ORR)

Description

ORR includes all patients whose cancer has a partial or complete response according to RECIST 1.1

Time Frame

average 19 weeks after the start of the neoadjuvant therapy

Title

Invasive disease-free survival (IDFS)

Description

Time Frame

5 years

Title

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

Description

Descriptive statistics will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped.

Time Frame

during treatment (16 weeks)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jiayi Wu, Dr.

Phone

0086-21-64370045

Ext

602268

pinkscorpio@163.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs