Clinical trial · Interventional
Trastuzumab and Exemestane in Treating Postmenopausal Women With Metastatic or Locally Advanced Breast Cancer
Phase II Study Of Herceptin And Exemestane For Treatment Of Postmenopausal Women With Metastatic Hormone-Responsive, 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): Unable to accrue subjects to the study after 2 years - closed per request by Data Monitoring Committee.
Summary
Brief summary (as posted)
RATIONALE: The monoclonal antibody trastuzumab can locate breast cancer cells that have HER2 on their surface 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 exemestane may fight breast cancer by reducing the production of estrogen. Combining trastuzumab with exemestane may be an effective treatment for breast cancer with high amounts of HER2. PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with exemestane in treating postmenopausal women who have metastatic or locally advanced HER2-positive breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| exemestane | Drug | Exemestane | ALIAS |
| trastuzumab | Biological | Trastuzumab | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed breast cancer
* Stage IV or locally advanced disease
* Staged by bone scan or CT scan of chest and/or abdomen within the past 6 weeks
* HER2/neu positive by fluorescent in situ hybridization (if 2+ by immunohistochemistry) or 3+ by immunohistochemistry
* Measurable disease defined by 1 of the following criteria:
* At least 1 dimension at least 1 cm by CT scan or other imaging scan
* At least 1 diameter at least 1 cm by plain x-ray (excluding bone lesions)
* Palpable lesion with both diameters at least 1 cm with caliper OR
* Evaluable disease defined by 1 of the following criteria:
* Positive bone scan
* Palpable masses with diameter less than 1 cm, masses with margins not clearly defined on CT scan or x-ray, or with both diameters less than 1 cm
* Bone scan and CA 27.29 if bone scan only evaluable disease
* Hormone receptor status:
* Estrogen receptor and/or progesterone receptor positive
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Female
Menopausal status
* Postmenopausal by 1 of the following criteria:
* 60 years of age and over
* 45 years of age and over with amenorrhea more than 12 months and an intact uterus
* Follicle-stimulating hormone levels within postmenopausal range
* Undergone bilateral oophorectomy
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Bilirubin less than 1.5 times upper limit of normal
Renal
* Creatinine less than 2 mg/dL
Cardiovascular
* Ejection fraction greater than 50%
Other
* Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior trastuzumab (Herceptin)
Chemotherapy
* Prior chemotherapy allowed
Endocrine therapy
* No prior exemestane
* No other prior hormonal agent (except tamoxifen)
Radiotherapy
* Not specified
Surgery
* Not specifiedReferences
Publications (0)
Data not yet available