Trastuzumab Combined With Chemotherapy or Endocrine Therapy to Treat Metastatic Luminal B2 Breast Cancer (SYSUCC-002)

July 13, 2020 updated by: Zhong-yu Yuan, Sun Yat-sen University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

392

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-Sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Palliative chemotherapy
Chemotherapy combined with trastuzumab. Chemotherapy could use the following drugs such as capecitabine , Vinorelbine, or Gemcitabine.
Drug: Chemotherapy combined with trastuzumab
Capecitabine , Vinorelbine, or Gemcitabine combined with trastuzumab
Other Names:
  • Gemcitabine
  • Capecitabine
  • Vinorelbine
  • trastuzumab
Experimental: Palliative endocrine therapy
Endocrine therapy combined with trastuzumab. Endocrine therapy could use tamoxifen or aromatase inhibitors including anastrozole, letrozole, or exemestane.
Drug: Endocrine therapy combined with trastuzumab
Tamoxifen or aromatase inhibitors (Anastrozole, Letrozole, or Exemestane) combined with trastuzumab
Other Names:
  • Tamoxifen
  • trastuzumab
  • aromatase inhibitors

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Study Chair: Zhong-yu Yuan, MD, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2013

Primary Completion (Actual)

May 31, 2020

Study Completion (Actual)

May 31, 2020

Study Registration Dates

First Submitted

September 18, 2013

First Submitted That Met QC Criteria

September 21, 2013

First Posted (Estimate)

September 25, 2013

Study Record Updates

Last Update Posted (Actual)

July 15, 2020

Last Update Submitted That Met QC Criteria

July 13, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSUCC-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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