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

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ClinicalTrials.gov Identifier: NCT01950182
Recruitment Status : Recruiting
First Posted : September 25, 2013
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Zhong-yu Yuan, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Endocrine therapy combined with trastuzumab Drug: Chemotherapy combined with trastuzumab Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 392 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

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:
  • Capecitabine
  • Vinorelbine
  • Gemcitabine
  • 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
  • aromatase inhibitors
  • trastuzumab




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950182


Contacts
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Contact: Zhong-yu Yuan, MD 86-20-87343794 yuanzhy@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Zhong-yu Yuan, MD    86-20-87343794    yuanzhygz@163.com   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Study Chair: Zhong-yu Yuan, MD Sun Yat-sen University

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Responsible Party: Zhong-yu Yuan, unYat-senU, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01950182     History of Changes
Other Study ID Numbers: SYSUCC-002
First Posted: September 25, 2013    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Zhong-yu Yuan, Sun Yat-sen University:
Luminal B2 subtype
First line treatment

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Capecitabine
Trastuzumab
Vinorelbine
Tamoxifen
Aromatase Inhibitors
Phenobarbital
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists