Phase 2
Completed N=11
Bendamustine and Erlotinib in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Breast Cancer
Source: ClinicalTrials.gov NCT00834678 ↗Enrolled (actual)
11
Serious AEs
27.3%
Results posted
Apr 2015
Primary outcomePrimary: Maximum-tolerated Dose of Bendamustine Hydrochloride (Phase I) — 120 mg/m^2
Summary
RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving bendamustine together with erlotinib may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of giving bendamustine together with erlotinib in treating patients with stage IIIB, stage IIIC, or stage IV breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum-tolerated Dose of Bendamustine Hydrochloride (Phase I) |
120 | — |
| PRIMARY Maximum-tolerated Dose of Erlotinib Hydrochloride (Phase I) |
150 | — |
| PRIMARY Dose-limiting Toxicity (Phase I) |
0; 1 | — |
| PRIMARY Progression-free Survival at 6 Months and 12 Months (Phase II) |
3.7 | — |
| SECONDARY Objective Response Rate (ORR) |
0; 1 | — |
| SECONDARY Clinical Benefit Rate (CBR) |
— | — |
| SECONDARY Duration of Response (DR) |
3.7 | — |
| SECONDARY Overall Survival (OS) |
10.8 | — |
| SECONDARY Relationship of EGFR Expression or Amplification, Basal-like Tumors, and DNA Damage-repair Checkpoint Activation With ORR, CBR, DR, and OS |
— | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer meeting 1 of the following criteria:
- Unresectable stage IIIB or IIIC disease
- Stage IV disease
- Must be negative for all of the following:
- Estrogen receptor ( 1,500/mm³
- Platelet count > 100,000/mm³
- Creatinine clearance > 40 mL/min
- Normal electrolytes (i.e., Na, K, and Ca normal; minor deviations are allowed if they do not impact on patient safety in the clinical judgment of the treating physician)
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN in the presence of documented liver metastases)
- Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN in the presence of liver or bone metastases)
- Not pregnant or nursing
- Fertile patients must use effective barrier contraception
- No uncontrolled intercurrent illness
- No active infection requiring systemic therapy
- Able to swallow oral medications and with no medical problems or prior surgeries that may interfere with the absorption of oral medications including the following:
- Uncontrolled nausea, vomiting, or diarrhea
- Lack of the physical integrity of the upper gastrointestinal tract
- Malabsorption syndrome
- No known hypersensitivity to bendamustine hydrochloride, mannitol, or erlotinib hydrochloride
- No prior malignancy in the past 5 years except for adequately treated basal cell or squamous cell skin carcinoma, or adequately treated stage I-II cancer for which the patient is in complete remission
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior adjuvant or neoadjuvant chemotherapy and 1 prior chemotherapy regimen in the metastatic setting allowed provided recovered from all acute toxicities
- No prior bendamustine hydrochloride or EGFR-directed therapy
- No other concurrent antineoplastic treatments, including radiotherapy, chemotherapy, biological therapy, hormonal therapy, immunotherapy, gene therapy, and surgery
- Intravenous bisphosphonates allowed
- No concurrent antiretroviral therapy for HIV-positive patients
- No other concurrent investigational agents
Data sourced from ClinicalTrials.gov (NCT00834678). 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. Informational only — not medical advice.