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

NCT01950182 | Completed Phase 3 DMC

• 1 other identifier: SYSUCC-002
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Luminal B2 subtype; First line treatment

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Palliative chemotherapy

ACTIVE COMPARATOR

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

Drug: Chemotherapy combined with trastuzumab

Palliative endocrine therapy

EXPERIMENTAL

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

Drug: Endocrine therapy combined with trastuzumab

Interventions

Endocrine therapy combined with trastuzumab DRUG

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

Also known as: Tamoxifen, aromatase inhibitors, trastuzumab

Palliative endocrine therapy

Chemotherapy combined with trastuzumab DRUG

Capecitabine , Vinorelbine, or Gemcitabine combined with trastuzumab

Also known as: Capecitabine, Vinorelbine, Gemcitabine, trastuzumab

Palliative chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older.
• Patients with an Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
• Histologically confirmed metastatic or local recurrence of breast cancer.
• ER positive and/or progesterone receptor (PR) positive, HER-2+ defined as immuno-histochemistry3+ staining or FISH+.
• Prior adjuvant Trastuzumab therapy is permitted, but disease-free interval (DFI) must be more than 12 months.
• Patients must have measurable or evaluable disease.
• Adequate bone marrow reserve with neutrophils \> 1000 and platelets \> 100,000.
• Adequate renal function with serum creatinine \< 2.0.
• 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.
• Adequate cardiac reserve with at least 45% of Left ventricular ejection fraction (LVEF) by echocardiogram.
• Able to give informed consent.
• Life expectancy of at least 12 weeks.

You may not qualify if:

• Pregnant or breast feeding.
• ECOG score ≧2
• DFI \<12 months.
• LVEF \< 45% by echocardiogram.
• Uncontrolled medical problems.
• Evidence of active acute or chronic infection.
• Hepatic, renal, or bone marrow dysfunction as detailed above.
• Concurrent malignancy or history of other malignancy within the last five years except as noted above.
• Known severe hypersensitivity to Trastuzumab.
• Patients were unable or unwilling to comply with program requirements.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Tamoxifen; Aromatase Inhibitors; Capecitabine; Vinorelbine; Gemcitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Zhong-yu Yuan, MD

  Sun Yat-sen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: unYat-senU

Study Record Dates

• First Submitted: September 18, 2013
• First Posted: September 25, 2013
• Study Start: September 16, 2013
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: July 15, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)