Phase 2
N=38
Chloroquine With Taxane Chemotherapy for Advanced or Metastatic Breast Cancer After Anthracycline Failure (CAT)
Breast Neoplasms · Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01446016 ↗Enrolled (actual)
38
Serious AEs
2.6%
Results posted
Feb 2022
Primary outcome: Primary: Overall Response Rate (ORR) — 45.16 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Paclitaxel (Drug); Docetaxel (Drug); Abraxane (Drug); Ixabepilone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The Methodist Hospital Research Institute
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) |
45.16 | — |
| SECONDARY Time to Progression Free Survival (PFS) |
12.4 | — |
| SECONDARY Time of Overall Survival (OS) |
25.4 | — |
| SECONDARY Number of Patients Who Experienced Grade 3 of Greater Adverse Events |
4 | — |
Summary
The major purpose of this research study is to better understand how therapy works on different patients. This study is being offered to patients with a diagnosis of advanced or metastatic breast cancer who have failed anthracycline based therapy.
The investigators want to see the response of breast cancer cell when treated with Chloroquine used in combination with chemotherapy. Chemotherapy is an anti-cancer drug that is given through your vein. The chemotherapy used in this study is either Taxane (Paclitaxel) or Taxane-like drugs (Abraxane, Ixabepilone or Docetaxel).
Eligibility Criteria
Inclusion Criteria
- Females with pathologically determined advanced or metastatic breast cancer.
- Have progressed after treatment with regimen that included an anthracycline.
- Have had at least 4 cycles of an anthracycline containing regimen or 2 cycles if progressing on treatment.
- Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors.
- ≥18 years of age.
- ECOG PS of 0, 1, or 2.
- Laboratory values within the following ranges:
- Hemoglobin ≥9.0gm/dL (≥1.5μmol/L); transfusions permitted.
- Absolute neutrophil count ≥1500/mm3 (1.5 x 109/L)
- Platelet count ≥100,000/mm3 (100 x 109/L)
- Creatinine (Cr) 500.
- Concurrent severe or uncontrolled medical disease (i.e., active systemic infection, diabetes, hypertension, coronary artery disease, congestive heart failure) that, in the opinion of the Investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study.
- Symptomatic central nervous system metastases. The patient must be stable after radiotherapy for ≥2 weeks and off corticosteroids for ≥1 week.
- Pregnant or nursing women.
- Hypersensitivity or intolerance to Chloroquine, Paclitaxel, Docetaxel, Abraxane, Ixabepilone or other Taxane like drugs.
- Severe renal insufficiency (CrCl <30mL/min [Cockcroft and Gault]).
- History of gastrointestinal bleeding, ulceration, or perforation.
- Concurrent use of potent CYP3A4 inhibitors, such as ketoconazole, itraconazole,clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole.
- Concurrent use of potent CYP3A4 inducers, such as dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbitol, and St. John's wort.
Data sourced from ClinicalTrials.gov (NCT01446016). 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.