Clinical trial · Interventional
Cisplatin, Paclitaxel, and Everolimus in Treating Patients With Metastatic Breast Cancer
A Phase Ib/II Study of Cisplatin, Paclitaxel, and RAD001 in Patients With Metastatic Breast Cancer
NCT01031446CI-TRIAL-00034655completedPhase 1 / Phase 2Results postedClinicalTrials.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)
RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus 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 cisplatin and paclitaxel together with everolimus may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects of giving cisplatin and paclitaxel together with everolimus and to see how well it works in treating patients with 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| everolimus | Drug | Everolimus | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- interventionNames
- Drug: cisplatin
- Drug: everolimus
- Drug: paclitaxel
- Other: laboratory biomarker analysis
Primary outcomes (3)
- measure
- Maximum Feasible Dose in Milligrams Per Meter Squared of Body Surface Area (mg/m2) of Cisplatin and Paclitaxel for Women With Metastatic Breast Cancer
- timeFrame
- at 8 weeks
- description
- The recommended dose for the Phase II trial will be the most prevalent dose delivered per week in Phase I that allows for safe and feasible administration of the medications.The maximum tolerated dose (MTD) is defined as the dose preceding that at which 2 or more of 3 patients experience dose-limiting toxicity (DLT) during the initial cycle of therapy. DLTs include Common Toxicity Criteria (CTC) Grade 4 neutropenia (absolute neutrophil count \[ANC\] \< 0.5 x 10 9/L for \> 5 days), febrile neutropenia (ANC \< 1.0 x 10 0/L with fever \> 38.5 degrees Centigrade) or documented infection associated with Grade 3-4 neutropenia, CTC Grade 4 thrombocytopenia \< 25 x 10 9/L or CTC Grade 3 \< 50-25 x 10 9/L thrombocytopenia with bleeding, and Grade 3-4 non-hematologic toxicity despite symptomatic therapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed invasive mammary carcinoma * Stage IV disease * Basal-like disease (triple-negative, hormone-refractory, HER2-negative) * No locally recurrent breast cancer * No symptomatic brain metastases * Patients with a history of brain metastases are eligible provided they are clinically stable for \> 3 weeks after completion of radiotherapy and are not taking steroids or therapeutic anticonvulsants that are cytochrome P450 3A4 (CYP3A4) modifiers * Patients with asymptomatic brain metastases are eligible provided they are not taking prophylactic anticonvulsants that are CYP3A4 modifiers PATIENT CHARACTERISTICS: * Pre- or post-menopausal * European Cooperative Oncology Group (ECOG) performance status 0-1 * Life expectancy ≥ 6 months * Absolute neutrophil count (ANC) ≥ 1,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Creatinine ≤ 1.5 times upper limit of normal (ULN) * Total bilirubin ≤ 1.5 times ULN (≤ 3 times ULN in the presence of liver metastasis) * Direct bilirubin will be measured in patients with Gilbert syndrome * serum glutamate oxaloacetate transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) ≤ 1.5 times ULN (≤ 3 times ULN in the presence of liver metastasis) * Alkaline phosphatase ≤ 3 times ULN (in the presence of liver metastasis) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment * Able to swallow and retain oral medication * No malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel * No concurrent uncontrolled illness including, but not limited to, any of the following: * Ongoing or active infection requiring parenteral antibiotics * Impaired lung function (chronic obstructive pulmonary disease or lung conditions requiring oxygen therapy) * New York Heart Association class III-IV congestive heart failure * Unstable angina pectoris, angioplasty, stenting, or myocardial infarction within the past 6 months * Uncontrolled hypertension (systolic BP \> 180 mm Hg or diastolic BP \> 100 mm Hg, found on 2 consecutive measurements separated by a 1-week period and despite adequate medical support) * Clinically significant cardiac arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia that is symptomatic or requires treatment \[grade 3 according to NCI Common Toxicity Criteria for Adverse Events v3.0\]) * Uncontrolled diabetes (hyperosmolar state, ketoacidosis, etc.) * Psychiatric illness or social situations that would compromise patient safety or limit compliance with study requirements including maintenance of a compliance/pill diary * No symptomatic neuropathy ≥ grade 2 * No other invasive cancer within the past 5 years except for completely resected basal cell or squamous cell carcinoma of the skin or successfully treated cervical carcinoma in situ * No hypersensitivity to paclitaxel or drugs using the vehicle Cremophor, Chinese hamster ovary cell products, or other recombinant human antibodies * No history of hepatitis B or C PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from prior therapy * Prior total cumulative life-time dose of doxorubicin ≤ 360 mg/m\^2 or epirubicin ≤ 640 mg/m\^2 * No more than 4 prior chemotherapy treatments in the metastatic setting (not including endocrine therapy or single-agent biologic therapy) * At least 2 weeks since prior investigational drugs * At least 14 days since prior and no concurrent herbal or dietary supplements * At least 14 days since prior and no concurrent CYP3A4 inducers * At least 7 days since prior and no concurrent CYP3A4 inhibitors * Concurrent radiotherapy to painful bone metastases or areas of impending bone fracture allowed provided radiotherapy is initiated before study entry * No other concurrent anticancer therapy (chemotherapy, radiotherapy, surgery, immunotherapy, hormonal therapy, biologic therapy)
References
Publications (0)
Data not yet available
No reference posted for this study.