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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01950182

Acronym

SYSUCC-002

Enrollment

392

Registered

2013-09-25

Start date

2013-09-16

Completion date

2020-05-31

Last updated

2020-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Luminal B2 subtype, First line treatment

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.

Interventions

DRUGEndocrine therapy combined with trastuzumab

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

DRUGChemotherapy combined with trastuzumab

Capecitabine , Vinorelbine, or Gemcitabine combined with trastuzumab

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026