Clinical trial · Interventional
Erlotinib Plus Docetaxel in Treating Patients With Stage IV or Recurrent Breast Cancer
A Phase II Study Of The Weekly Administration Of Docetaxel In Combination With The Epidermal Growth Factor Receptor Inhibitor OSI-774 In Recurrent And/Or Metastatic Breast Cancer
NCT00054275CI-TRIAL-00020960completedPhase 2Results postedClinicalTrials.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: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with docetaxel may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining erlotinib with docetaxel in treating patients who have stage IV or recurrent 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 |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Erlotinib Plus Docetaxel
- interventionNames
- Drug: docetaxel
- Drug: erlotinib hydrochloride
Primary outcomes (1)
- measure
- Disease Response (Tumor Measurements)Per RECIST Criteria v. 2000
- timeFrame
- after 6 course (6 months) of combination therapy
- description
- Response and progression will be evaluated in this study using the criteria by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive Disease: At least a 20% increase in the sum of the LD of target lesions. Stable Disease: Neither sufficient shrinkage nor sufficient increase.
Secondary outcomes (2)
- measure
- Progression Free Survival(PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed stage IV or recurrent adenocarcinoma of the breast * Measurable disease * Disease recurrence must not be within 1 year of receiving prior adjuvant docetaxel * Stable brain metastases allowed * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Male or female Menopausal status * Not specified Performance status * ECOG (Eastern Cooperative Oncology Group) 0-2 OR * Karnofsky 60-100% Life expectancy * More than 6 months Hematopoietic * WBC(White Blood Count) at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Hemoglobin at least 8 g/dL Hepatic * Bilirubin normal * AST(aspartate aminotransferase)/ALT(alanine aminotransferase) no greater than 2.5 times upper limit of normal Renal * Creatinine normal OR * Creatinine clearance at least 60 mL/min * No clinically significant proteinuria * No significant impairment of renal function Cardiovascular * No New York Heart Association class III or IV heart disease * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No inadequately controlled hypertension Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception * No prior severe hypersensitivity reaction to docetaxel or drugs formulated with polysorbate 80 * No other malignancy within the past 10 years except inactive nonmelanoma skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast, or bilateral breast cancer * No ongoing or active infection * No peripheral neuropathy greater than grade 1 * No other concurrent uncontrolled medical condition that would preclude study participation * No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * Prior trastuzumab (Herceptin) allowed Chemotherapy * See Disease Characteristics * No prior chemotherapy for recurrent or metastatic disease * Prior adjuvant chemotherapy allowed Endocrine therapy * Prior hormonal therapy allowed Radiotherapy * Not specified Surgery * Not specified Other * No other concurrent investigational agents
References
Publications (0)
Data not yet available
No reference posted for this study.