Clinical trial · Interventional
Erlotinib Plus Chemotherapy for Treatment of Triple Negative Breast Cancer
Phase II Trial of Neoadjuvant Erlotinib Plus Chemotherapy for Treatment of ER Negative, PgR Negative and HER-2 Negative Primary Breast Cancer
NCT00491816CI-TRIAL-00025539unknownPhase 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)
Primary Study Objective: To assess the pathological complete response rate (pCR) with 4-6 cycles of neoadjuvant chemotherapy plus erlotinib in patients with triple negative 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 |
|---|---|---|---|
| Erlotinib with neoadjuvant chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- erlotinib with neoadjuvant chemotherapy
- description
- Study drug, erlotinib, is administered along with neoadjuvant chemotherapy. Adjuvant therapy given at discretion of treating physician. Once adjuvant therapy is completed, all patients will receive erlotinib 150 mg daily for 1 year.
- interventionNames
- Drug: Erlotinib with neoadjuvant chemotherapy
Primary outcomes (1)
- measure
- Pathological complete response rate (pCR)
- timeFrame
- After 18 weeks of neoadjuvant therapy
Secondary outcomes (4)
- measure
- Estimation of change in ki-67 (proliferation) after 2 cycles of neoadjuvant carboplatin/docetaxel based chemotherapy
- timeFrame
- After 2 cycles (6 weeks) of therapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patient ≥ 18 years of age * Histologically proven stage II or III adenocarcinoma of the breast * Patients must be candidates for neoadjuvant treatment (tumor size \> 2 cm, T2, T3, T4 and/or clinical N1 or N2) * Estrogen Receptor negative, Progesterone Receptor negative and HER-2 negative disease (IHC 0 or 1+ and/or FISH negative) * Performance status of 2 or better * No prior chemotherapy or endocrine therapy * If female of childbearing potential, pregnancy test is negative and willing to use effective contraception while on treatment and for at least 3 months after the last dose of study drug * Adequate bone marrow function: neutrophils ≥ 1500/mm3, platelet count ≥ 100,000/mm3, and hemoglobin ≥ 11 g/dL * Adequate kidney function: serum creatinine ≤ 1.5 mg/dl and/or creatinine clearance of ≥ 60 mL/min * Adequate hepatic function: transaminases \< 2 x upper limit of normal and total bilirubin ≤ 1.5 mg/dL * Patients must have a serum albumin ≥ 3.0 g/dL * Patients must have a Prothrombin Time, Partial Thromboplastin Time within normal limits * Patients must be informed of the investigational nature of the study, and must sign an informed consent in accordance with the institutional rules * Pretreatment lab values must be performed within 14 days of patient registration, and other baseline studies within 30 days * Patients will have a baseline mammogram, bone scan, CT chest and abdomen Exclusion Criteria: * Patients with metastatic disease are excluded from study * The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of drugs in this protocol or place the subject at undue risk for treatment complications * Pregnancy or lactation * Prior use of an Epidermal growth factor receptor inhibitor * Patients with a history of chronic pulmonary disease are excluded from study * Patients with inadequate laboratory values (as defined above) are excluded from study * Patients with NCI common toxicity criteria (CTC) grade 2 or greater peripheral neuropathy are excluded from study * Patients with active infection are excluded from study * Patients with concomitant or previous malignancies within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, are excluded from study * Patients with emotional limitations are excluded from study * Patients with inflammatory breast cancer will be excluded
References
Publications (0)
Data not yet available
No reference posted for this study.