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Trastuzumab With or Without Tamoxifen in Treating Women With Progressive Stage IV Breast Cancer

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ClinicalTrials.gov Identifier: NCT00053339
Recruitment Status : Withdrawn (The study was not activated.)
First Posted : January 28, 2003
Last Update Posted : July 12, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Description
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Brief Summary:

RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combining trastuzumab with tamoxifen may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of trastuzumab with or without trastuzumab in treating women who have invasive stage IV breast cancer.


Condition or disease Intervention/treatment Phase
Stage IV Breast Cancer Recurrent Breast Cancer Drug: tamoxifen Drug: trastuzumab Phase 3

Detailed Description:

OBJECTIVES:

  • Compare time to progression in women with progressive, stage IV, estrogen or progesterone receptor- and HER2/neu-positive breast cancer treated with trastuzumab (Herceptin) with or without tamoxifen.
  • Correlate response with type of measurement (immunohistochemistry or fluorescent in situ hybridization) of HER2/neu expression in patients treated with these regimens.
  • Compare objective response rate (complete or partial response) in patients treated with these regimens.

OUTLINE: This is a randomized study. Patients are stratified according to prior adjuvant treatment (yes vs no), ECOG performance status (0-1 vs 2), and prior aromatase inhibitor treatment (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive trastuzumab (Herceptin) IV over 60-90 minutes on day 1.
  • Arm II: Patients receive trastuzumab as in arm I and oral tamoxifen once daily on days 1-21.

In both arms, treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 5 years.

PROJECTED ACCRUAL: A total of 280 patients (140 per treatment arm) will be accrued for this study within 28 months.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Randomized Study of Trastuzumab (Herceptin) With or Without Tamoxifen in Women With Progressive, Stage IV, Estrogen or Progesterone Receptor- and HER2/Neu-Positive Breast Cancer

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: trastuzumab

Patients receive trastuzumab (Herceptin) IV over 60-90 minutes on day 1.

Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 5 years.

 Drug: trastuzumab
Experimental: trastuzumab + tamoxifen

Patients receive trastuzumab V over 60-90 minutes on day 1 and oral tamoxifen once daily on days 1-21.

In both arms, treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 5 years.

 Drug: tamoxifen
Drug: trastuzumab


Outcome Measures
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Primary Outcome Measures :
  1. Time to progression [ Time Frame: Up to 5 years ]

Secondary Outcome Measures :
  1. response [ Time Frame: Up to 5 years ]
  2. response rate [ Time Frame: Up to 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive stage IV breast cancer
  • Hormone receptor status:
  • HER2/neu positive (3+ by immunohistochemical [IHC] assay or fluorescent in situ hybridization [FISH])
  • Estrogen receptor or progesterone receptor positive
  • Measurable or evaluable disease
  • Must have disease progression within 6 months of initiation of tamoxifen (administered in the adjuvant or metastatic setting) or during aromatase inhibitor therapy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Female

Performance status

  • ECOG 0-2

Hematopoietic

  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 75,000/mm^3

Hepatic

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT and SGPT no greater than 2.5 times ULN

Cardiovascular

  • LVEF normal by MUGA

Other

  • Not pregnant or nursing
  • Fertile patients must use effective nonhormonal contraception during and for at least 2 months after study completion
  • No other concurrent active malignancy except nonmelanoma skin cancer
  • Patients who have completed prior therapy and are at less than 30% risk of relapse are not considered to have an active malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior trastuzumab (Herceptin) in the adjuvant or metastatic setting

Chemotherapy

  • No more than 1 prior chemotherapy regimen in the metastatic setting
  • No concurrent chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • No more than 1 prior hormonal therapy regimen for metastatic disease
  • Prior aromatase inhibitor therapy administered in the first-line metastatic or adjuvant setting is allowed provided there is disease progression on tamoxifen
  • No other concurrent hormonal therapy except the following:
  • Steroids for adrenal failure
  • Hormones for nondisease-related conditions (e.g., insulin for diabetes)
  • Intermittent use of dexamethasone as an antiemetic
  • Vaginal estrogen (or Estring®) for vaginal dryness

Radiotherapy

  • No concurrent palliative radiotherapy except whole brain irradiation for CNS disease

Other

  • Concurrent bisphosphonates allowed
  • No concurrent cardioprotective drugs
Contacts and Locations
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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): NCT00053339


Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
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Study Chair: Joanne E. Mortimer, MD Sentara Cancer Center
More Information
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Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00053339    
Other Study ID Numbers: CALGB-49903
CDR0000269409 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 28, 2003    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
 Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents