Clinical trial · Interventional
Trastuzumab and Letrozole in Treating Postmenopausal Women With Progressive Advanced Breast Cancer
Trastuzumab Monotherapy Followed By the Combination of Trastuzumab and Letrozole in Post-Menopausal Women With ER-Positive, HER-2 Positive Advanced Breast Cancer Resistant to a Nonsteroidal Aromatase Inhibitor: A Multicenter Two-Step Phase II Trial
NCT00238290CI-TRIAL-00038623completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. Giving trastuzumab together with letrozole after disease progression may be an effective treatment for breast cancer. PURPOSE: This phase II trial is studying how well giving trastuzumab together with letrozole works in treating postmenopausal women with progressive advanced 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Trastuzumab + Letrozole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes once in weeks 1-3 OR once in week 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression after 9 weeks receive trastuzumab as before and oral letrozole once daily in the absence of further disease progression or unacceptable toxicity.
- interventionNames
- Drug: Trastuzumab + Letrozole
Primary outcomes (1)
- measure
- Objective response rate as assessed by CT scan or MRI every 3 months
- timeFrame
- 3 months
Secondary outcomes (3)
- measure
- Time to tumor progression (TTP) every 3 months
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed breast cancer
* Advanced disease
* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion outside previously irradiated areas that is ≥ 20 mm OR ≥ 10 mm if the slice thickness of the CT scan or MRI is ≤ 5 mm
* No nonmeasurable lesions as the only site of measurable disease, including any of the following:
* Osteoblastic bone metastases
* Ascites
* Pleural or pericardial effusions
* Carcinomatous lymphangitis of the lung
* Progressive disease after prior treatment with a nonsteroidal aromatase inhibitor (e.g., letrozole or anastrozole) in an adjuvant or advanced disease setting
* HER-2 amplification ≥ 2 by fluorescence in situ hybridization
* No clinical symptoms or history of CNS or leptomeningeal metastases (no imaging is required)
* No visceral involvement with risk for organ dysfunction
* Hormone receptor status:
* Estrogen receptor- and/or progesterone receptor-positive tumor
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Female
Menopausal status
* Postmenopausal, defined by 1 of the following:
* At least 55 years of age
* Less than 55 years of age with spontaneous cessation of menses for ≥ 1 year
* Less than 55 years of age with spontaneous cessation of menses within the past year, but amenorrheic with biochemical evidence of postmenopausal status
* Underwent prior bilateral oophorectomy
* Radiation or chemically induced menopause (treatment with luteinizing hormone-releasing hormone antagonists must continue during study treatment)
Performance status
* WHO 0-1
Life expectancy
* Not specified
Hematopoietic
* WBC ≥ 3,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* AST and ALT ≤ 2 times upper limit of normal
Renal
* Creatinine clearance \> 30 mL/min
Cardiovascular
* No uncontrolled cardiac disease, including any of the following:
* Unstable angina
* Arrhythmia
* Hypertension
* No history of congestive heart failure
* No myocardial infarction within the past 6 months
* LVEF \> 50% by echocardiogram
Pulmonary
* No severe dyspnea at rest
Other
* No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or localized nonmelanoma skin cancer
* No psychiatric disability that would preclude study participation or giving informed consent
* No active autoimmune disease
* No uncontrolled diabetes
* No other serious underlying medical condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior trastuzumab (Herceptin®)
Chemotherapy
* Prior neoadjuvant or adjuvant chemotherapy allowed
* No prior palliative chemotherapy
Endocrine therapy
* See Disease Characteristics
Radiotherapy
* See Disease Characteristics
Surgery
* Not specified
Other
* More than 1 month since prior experimental drugs on another clinical trial
* No concurrent drugs that contraindicate study treatment
* No other concurrent anticancer drugs
* No other concurrent investigational drugsReferences
Publications (1)
- RESULTKoeberle D, Ruhstaller T, Jost L, Pagani O, Zaman K, von Moos R, Oehlschlegel C, Crowe S, Pilop C, Thuerlimann B; Swiss Group for Clinical Cancer Research (SAKK). Combination of trastuzumab and letrozole after resistance to sequential trastuzumab and aromatase inhibitor monotherapies in patients with estrogen receptor-positive, HER-2-positive advanced breast cancer: a proof-of-concept trial (SAKK 23/03). Endocr Relat Cancer. 2011 Mar 9;18(2):257-64. doi: 10.1530/ERC-10-0317. Print 2011 Apr. PMID 21317203