Chloroquine With Taxane Chemotherapy for Advanced or Metastatic Breast Cancer After Anthracycline Failure (CAT)

• Register: ClinicalTrials.gov
• Last refreshed on: 30 January 2023
• Main ID: NCT01446016
• Date of registration: 29/09/2011
• Prospective Registration: No
• Primary sponsor: The Methodist Hospital Research Institute
• Public title: Chloroquine With Taxane Chemotherapy for Advanced or Metastatic Breast Cancer After Anthracycline Failure (CAT) CAT
• Scientific title: Phase II Study of The Efficacy And Safety of Chloroquine (C) in CombinAtion With Taxane or Taxane-like (T) Chemo Agents in The Treatment of Patients With Advanced or Metastatic Breast Cancer Who Have Failed Anthracycline Chemo Base Therapy
• Date of first enrolment: September 2011
• Target sample size: 38
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01446016
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Jenny C Chang, MD
• Affiliation: The Methodist Hospital Research Institute

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Females with pathologically determined advanced or metastatic breast cancer.

2. Have progressed after treatment with regimen that included an anthracycline.

3. Have had at least 4 cycles of an anthracycline containing regimen or 2 cycles if
progressing on treatment.

4. Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors.

5. =18 years of age.

6. ECOG PS of 0, 1, or 2.

7. 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) <2 X the upper limit of normal (ULN), Cr clearance (CrCl) =30 by
Cockcroft and Gault

- Alanine aminotransferase and aspartate aminotransferase <2 X the ULN; if liver
metastases are present then must be <5 X the ULN, Bilirubin <2 X the ULN,
Potassium within normal limits, Magnesium within normal limits

8. Negative serum pregnancy test at the time of first dose for women of childbearing
potential (WOCBP). For WOCBP, adequate contraception must be used throughout the
study. For this study, acceptable methods of contraception include a reliable
intrauterine device or a spermicide in combination with a barrier method. Women who
are already on hormonal forms of birth control may continue that treatment but must
also use a barrier method.

9. Ability to understand the requirements of the study, provide written informed consent
and authorization of use and disclosure of protected health information, and agree to
abide by the study restrictions and return for the required assessments.

10. Patient must be willing to undergo breast biopsies as required by the study protocol.

Exclusion Criteria:

1. Radiation therapy within 2 weeks; or chemotherapy or non-cytotoxic investigational
agents within 4 weeks of initiating study treatment.

2. Evidence of New York Heart Association class III or greater cardiac disease.

3. History of myocardial infarction, stroke, ventricular arrhythmia, or symptomatic
conduction abnormality within 12 months.

4. History of congenital QT prolongation.

5. QT >500.

6. 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.

7. Symptomatic central nervous system metastases. The patient must be stable after
radiotherapy for =2 weeks and off corticosteroids for =1 week.

8. Pregnant or nursing women.

9. Hypersensitivity or intolerance to Chloroquine, Paclitaxel, Docetaxel, Abraxane,
Ixabepilone or other Taxane like drugs.

10. Severe renal insufficiency (CrCl <30mL/min [Cockcroft and Gault]).

11. History of gastrointestinal bleeding, ulceration, or perforation.

12. Concurrent use of potent CYP3A4 inhibitors, such as ketoconazole,
itraconazole,clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir,
telithromycin, and voriconazole.

13. Concurrent use of potent CYP3A4 inducers, such as dexamethasone, phenytoin,
carbamazepine, rifampin, rifabutin, rifapentine, phenobarbitol, and St. John's wort.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Breast Neoplasms

Intervention(s)

Drug: Abraxane

Drug: Docetaxel

Drug: Paclitaxel

Drug: Ixabepilone

Primary Outcome(s)

Overall Response Rate (ORR) [Time Frame: 3-week cycles for maximum of 6 cycles (4.5 months)]

Secondary Outcome(s)

Time to Progression Free Survival (PFS) [Time Frame: 25.4 months (median)]

Time of Overall Survival (OS) [Time Frame: a median of 25.4 months, up to 83.5 months]

Number of Patients Who Experienced Grade 3 of Greater Adverse Events [Time Frame: 25.4 months (median)]

Secondary ID(s)

0811-0147

Pro00006423

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 01/02/2022
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01446016