Clinical trial · Interventional
Bendamustine and Erlotinib in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Breast Cancer
Phase I/II Study of Bendamustine and Erlotinib for Metastatic or Locally Advanced Triple Negative Breast Cancer
- 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: 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.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bendamustine | Drug | Bendamustine | ALIAS |
| erlotinib | Drug | Erlotinib | ALIAS |
| Maintenance erlotinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bendamustine and Erlotinib
- description
- Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 - 21 of each 28 day cycle.
- interventionNames
- Drug: bendamustine
- Drug: erlotinib
- Drug: Maintenance erlotinib
Primary outcomes (4)
- measure
- Maximum-tolerated Dose of Bendamustine Hydrochloride (Phase I)
- timeFrame
- Up to two years
- description
- 28 day cycle included intravenous bendamustine on days 1 and 2.
- measure
- Maximum-tolerated Dose of Erlotinib Hydrochloride (Phase I)
- timeFrame
- Up to two years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 (\< 10%)
* Progesterone receptor (\<10%)
* HER-2 (negative FISH, IHC 0 - 1+, or IHC +2 with negative FISH)
* Measurable or evaluable disease
* No symptomatic or progressive CNS (central nervous system) metastases
* Previously treated CNS metastases allowed provided all of the following criteria are met:
* At least 8 weeks since prior radiation to brain or CNS metastases
* No concurrent steroids
* No leptomeningeal disease
PATIENT CHARACTERISTICS:
* Menopausal status not specified
* ECOG (Eastern Cooperative Oncology Group) performance status 0-2
* Life expectancy ≥ 6 months
* WBC \> 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 agentsReferences
Publications (1)
- RESULTLayman RM, Ruppert AS, Lynn M, Mrozek E, Ramaswamy B, Lustberg MB, Wesolowski R, Ottman S, Carothers S, Bingman A, Reinbolt R, Kraut EH, Shapiro CL. Severe and prolonged lymphopenia observed in patients treated with bendamustine and erlotinib for metastatic triple negative breast cancer. Cancer Chemother Pharmacol. 2013 May;71(5):1183-90. doi: 10.1007/s00280-013-2112-2. Epub 2013 Feb 21. PMID 23430121