Trastuzumab Combined With Chemotherapy or Endocrine Therapy to Treat Metastatic Luminal B2 Breast Cancer

Breast Cancer Clinical Trial

— SYSUCC-002  

Official title:

A Multicentre, Randomized Study of Trastuzumab Combined With Chemotherapy or Endocrine Therapy as the First Line Treatment for Patients With Metastatic Luminal B2 Breast Cancer Subtype

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01950182
• Other study ID #: SYSUCC-002
• Status: Completed
• Phase: Phase 3
• Start date: September 16, 2013
• Est. completion date: May 31, 2020

Study information

• Verified date: July 2020
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to compare progression-free survival (PFS) of patients with metastatic Luminal B2 breast cancer subtype randomised to treatment with Trastuzumab Combined With Chemotherapy or Endocrine Therapy.

Description:

This is a non-inferiority study to examine Trastuzumab combined with chemotherapy or endocrine therapy in patients with metastatic Luminal B2 breast cancer subtype. The main purposes of this study are to test the safety and clinical benefit of Trastuzumab combined with chemotherapy or endocrine therapy in treating Luminal B2 breast cancer (hormone receptor positive and human epidermal growth factor receptor (HER2) positive or amplification). This multicentre, randomized study is designed to recruit up to 392 subjects to identify 196 research subjects for each study treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 392
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age 18 years or older.

2. Patients with an Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.

3. Histologically confirmed metastatic or local recurrence of breast cancer.

4. ER positive and/or progesterone receptor (PR) positive, HER-2+ defined as immuno-histochemistry3+ staining or FISH+.

5. Prior adjuvant Trastuzumab therapy is permitted, but disease-free interval (DFI) must be more than 12 months.

6. Patients must have measurable or evaluable disease.

7. Adequate bone marrow reserve with neutrophils > 1000 and platelets > 100,000.

8. Adequate renal function with serum creatinine < 2.0.

9. Adequate hepatic reserve with serum bilirubin < 2.0, alanine transaminase(ALT) < 3 times the upper limit of normal, and alkaline phosphatase < 5 times the upper limit of normal.

10. Adequate cardiac reserve with at least 45% of Left ventricular ejection fraction (LVEF) by echocardiogram.

11. Able to give informed consent.

12. Life expectancy of at least 12 weeks.

Exclusion Criteria:

1. Pregnant or breast feeding.

2. ECOG score ?2

3. DFI <12 months.

4. LVEF < 45% by echocardiogram.

5. Uncontrolled medical problems.

6. Evidence of active acute or chronic infection.

7. Hepatic, renal, or bone marrow dysfunction as detailed above.

8. Concurrent malignancy or history of other malignancy within the last five years except as noted above.

9. Known severe hypersensitivity to Trastuzumab.

10. Patients were unable or unwilling to comply with program requirements.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Endocrine therapy combined with trastuzumab
Tamoxifen or aromatase inhibitors (Anastrozole, Letrozole, or Exemestane) combined with trastuzumab
• Chemotherapy combined with trastuzumab
Capecitabine , Vinorelbine, or Gemcitabine combined with trastuzumab

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival (PFS)	The interim analysis and the final analysis are expected ot occur 18 and 36 months after the end of recruitment.	36 months