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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04236310
• Other study ID #: RJBC2001
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 15, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2020
• Source: Ruijin Hospital
• Contact: Jiayi Wu, Dr.
• Phone: 0086-21-64370045
• Email: pinkscorpio[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 37
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• ER-positive Breast Cancer
• HER2-positive Breast Cancer

Intervention

Drug:
• 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
• Anastrozole
Anastrozole 1md, orally once daily for 16 weeks (For premenopausal women, ovarian suppression may be considered)
• Pyrotinib
Pyrotinib 400mg once daily for 16 weeks
• Trastuzumab
Trastuzumab 6mg/kg (loading dose, 8mg/kg), infusion once every 3-week cycle for 5 cycles.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ruijin Hospital	Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ki67 changes from baseline to at surgery	Ki67 changes from baseline to at surgery	average 19 weeks after the start of the neoadjuvant therapy
Secondary	Pathological complete response (ypT0/is ypN0) rate	Absence of invasive cancer in the breast and axillary nodes, irrespective of ductal carcinoma in situ.	average 19 weeks after the start of the neoadjuvant therapy
Secondary	Objective response rate (ORR)	ORR includes all patients whose cancer has a partial or complete response according to RECIST 1.1	average 19 weeks after the start of the neoadjuvant therapy
Secondary	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)	5 years
Secondary	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.	during treatment (16 weeks)