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

NCT00053339 | Withdrawn Phase 3

• 2 other identifiers: CALGB-49903CDR0000269409
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stage IV Breast Cancer; Recurrent Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Time to progression

  Up to 5 years

Secondary Outcomes (2)

• response

  Up to 5 years

• response rate

  Up to 5 years

Study Arms (2)

trastuzumab

EXPERIMENTAL

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

trastuzumab + tamoxifen

EXPERIMENTAL

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

Interventions

tamoxifen DRUG

trastuzumab + tamoxifen

trastuzumab DRUG

trastuzumab; trastuzumab + tamoxifen

Eligibility Criteria

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tamoxifen; Trastuzumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Joanne E. Mortimer, MD

  Sentara Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2003
• First Posted: January 28, 2003
• Last Updated: July 12, 2016

Record last verified: 2016-07