Clinical trial · Interventional
Irinotecan and Etoposide in Treating Patients With Recurrent, Locally Advanced, or Metastatic Breast Cancer
A Phase II Study: Irinotecan and Etoposide as Treatment for Refractory, Metastatic 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 irinotecan and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving irinotecan together with etoposide works in treating patients with recurrent, locally advanced, or metastatic 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 |
|---|---|---|---|
| Etoposide | Drug | Etoposide | ALIAS |
| Irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Etoposide and Irinotecan hydrochloride
- description
- Irinotecan 100 mg/m2 IV days 1 and 15. Etoposide 50 mg PO x14 days followed by 2 weeks off.
- interventionNames
- Drug: Etoposide
- Drug: Irinotecan hydrochloride
Primary outcomes (1)
- measure
- Median Time to Progression
- timeFrame
- Measured time from the start of treatment to the time the patient is first recorded as having disease progression or dies. If no progression or death while being followed via tumor assessment, censored at last date known alive, assesed up to 13 months
- description
- Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of locally advanced or metastatic breast cancer
* Recurrent, refractory or progressive disease after receiving prior anthracycline, taxane, and capecitabine therapy
* Prior anthracycline and taxane therapy may have been as neoadjuvant, or adjuvant therapy if disease progression is documented within a year of completing that agent
* Received prior capecitabine therapy for metastatic or recurrent disease
* Measurable disease
* Bone metastases requires other disease present that can be measured
* No brain metastases, unless documented to be controlled post-completion of local therapy (surgery and/or radiation therapy) for at least 4 weeks
* No meningeal carcinomatosis
* No malignant effusion as the only site of disease recurrence
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Menopausal status not specified
* Performance status of 0-2
* Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 40 mL/min
* Hemoglobin ≥ 10 g/dL
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Bilirubin normal or hyperbilirubinemia \< grade 1 (unless due to Gilbert syndrome with elevated total but normal levels of conjugated bilirubin)
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other non-breast malignancy, except nonmelanoma skin cancer
* No other serious underlying medical condition, that in the opinion of the treating physician, would make study protocol unreasonably hazardous for the patient or would preclude the patient's ability to comply with the study protocol
PRIOR CONCURRENT THERAPY:
* See Disease Characteristic
* Recovered from all prior chemotherapy or radiotherapy to NCI CTC grade ≤ 1
* Unlimited documented prior chemotherapy regimens allowed
* No prior irinotecan hydrochloride or etoposide
* No Hypericum perforatum (St. John's wort) 14 days prior to, during, or 7 days after completion of study therapy
* At least 7 days since prior and no concurrent phenytoin, carbamazepine, phenobarbital, or any other enzyme-inducing anticonvulsant drug (EIACD)
* No concurrent aprepitantReferences
Publications (1)
- DERIVEDSegar JM, Reed D, Stopeck A, Livingston RB, Chalasani P. A Phase II Study of Irinotecan and Etoposide as Treatment for Refractory Metastatic Breast Cancer. Oncologist. 2019 Dec;24(12):1512-e1267. doi: 10.1634/theoncologist.2019-0516. Epub 2019 Aug 5. PMID 31383812