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

NCT ID: NCT01950182

Last Updated: 2020-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 392 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-16
• Study Completion Date: 2020-05-31

Brief 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.

Detailed 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Palliative chemotherapy

Chemotherapy combined with trastuzumab. Chemotherapy could use the following drugs such as capecitabine , Vinorelbine, or Gemcitabine.

Group Type: ACTIVE_COMPARATOR

Chemotherapy combined with trastuzumab

Intervention Type: DRUG

Capecitabine , Vinorelbine, or Gemcitabine combined with trastuzumab

Palliative endocrine therapy

Endocrine therapy combined with trastuzumab. Endocrine therapy could use tamoxifen or aromatase inhibitors including anastrozole, letrozole, or exemestane.

Group Type: EXPERIMENTAL

Endocrine therapy combined with trastuzumab

Intervention Type: DRUG

Tamoxifen or aromatase inhibitors (Anastrozole, Letrozole, or Exemestane) combined with trastuzumab

Interventions

Endocrine therapy combined with trastuzumab

Tamoxifen or aromatase inhibitors (Anastrozole, Letrozole, or Exemestane) combined with trastuzumab

Intervention Type: DRUG

Chemotherapy combined with trastuzumab

Capecitabine , Vinorelbine, or Gemcitabine combined with trastuzumab

Intervention Type: DRUG

Other Intervention Names

Tamoxifen; aromatase inhibitors; trastuzumab; Capecitabine; Vinorelbine; Gemcitabine; trastuzumab

Eligibility Criteria

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.

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

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Zhong-yu Yuan

unYat-senU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhong-yu Yuan, MD

Role: STUDY_CHAIR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

SYSUCC-002

Identifier Type: -

Identifier Source: org_study_id