Clinical trial · Interventional
Trastuzumab With or Without Tamoxifen in Treating Women With Progressive Stage IV Breast Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was not activated.
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tamoxifen | Drug | Tamoxifen | ALIAS |
| trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- trastuzumab
- description
- 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.
- interventionNames
- Drug: trastuzumab
- type
- EXPERIMENTAL
- label
- trastuzumab + tamoxifen
- description
- 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.
- interventionNames
- Drug: tamoxifen
- Drug: trastuzumab
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available