Phase 2
N=39
Erlotinib Plus Docetaxel in Treating Patients With Stage IV or Recurrent Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00054275 ↗Enrolled (actual)
39
Serious AEs
71.8%
Results posted
Mar 2012
Primary outcome: Primary: Disease Response (Tumor Measurements)Per RECIST Criteria v. 2000 — 11; 14; 3 participants — p=0.95
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- docetaxel (Drug); erlotinib hydrochloride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Paula Silverman, MD
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Response (Tumor Measurements)Per RECIST Criteria v. 2000 |
11; 14; 3 | 0.95 |
| SECONDARY Progression Free Survival(PFS) |
8.4 | — |
| SECONDARY Overall Survival as of 2008 |
22.3 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00054275). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.