Trial Outcomes & Findings for Chloroquine With Taxane Chemotherapy for Advanced or Metastatic Breast Cancer After Anthracycline Failure (CAT) (NCT NCT01446016)

Last Updated: 2023-01-23

Results Overview

To determine the anti-tumor activity of the combination of Chloroquine + Taxane or Taxane-like chemo agents (Paclitaxel, Docetaxel, Abraxane, Ixabepilone) (C/T) measured by overall Response Rate (ORR) defined as percentage of patients having complete or partial response in therapy per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate. The study was designed to compare the ORR with the published percentage of 30% (docetaxel 100 mg/ml2 every 3 weeks for maximum of 10 cycles).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

38 participants

Primary outcome timeframe

3-week cycles for maximum of 6 cycles (4.5 months)

Results posted on

2023-01-23

Participant Flow

38 patients were enrolled in the study and 31 patients were evaluated for response.

Participant milestones

Participant milestones
Measure	Chloroquine With Taxane or Taxane-Like (Paclitaxel, Docetaxel, Abraxane, Ixabepilone) Chemotherapy Chloroquine (250 mg) was given daily orally with either Paclitaxel or Docetaxel or Abraxane or Ixabepilone chemotherapy every 3 weeks (1 cycle) for a maximum of 6 cycles. Paclitaxel: Chloroquine 250mg po daily together with Paclitaxel (Taxane) 175 mg/m2 three hours infusion every three weeks. Docetaxel: Chloroquine 250mg po daily together with docetaxel 75 mg/m2 administered intravenously over one hour every three weeks Abraxane: Chloroquine 250mg po daily together with Abraxane 260 mg/m2 administered intravenously over 30 minutes every three weeks. Ixabepilone: Chloroquine 250mg po daily together with Ixabepilone is 40 mg/m2 administered intravenously over three hours every three weeks.
Overall Study STARTED	38
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Chloroquine With Taxane or Taxane-Like (Paclitaxel, Docetaxel, Abraxane, Ixabepilone) Chemotherapy Chloroquine (250 mg) was given daily orally with either Paclitaxel or Docetaxel or Abraxane or Ixabepilone chemotherapy every 3 weeks (1 cycle) for a maximum of 6 cycles. Paclitaxel: Chloroquine 250mg po daily together with Paclitaxel (Taxane) 175 mg/m2 three hours infusion every three weeks. Docetaxel: Chloroquine 250mg po daily together with docetaxel 75 mg/m2 administered intravenously over one hour every three weeks Abraxane: Chloroquine 250mg po daily together with Abraxane 260 mg/m2 administered intravenously over 30 minutes every three weeks. Ixabepilone: Chloroquine 250mg po daily together with Ixabepilone is 40 mg/m2 administered intravenously over three hours every three weeks.
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	1
Overall Study Toxicity	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chloroquine With Taxane or Taxane-Like (Paclitaxel, Docetaxel, Abraxane, Ixabepilone) Chemotherapy n=38 Participants Chloroquine (250 mg) was given daily orally with either Paclitaxel or Docetaxel or Abraxane or Ixabepilone chemotherapy every 3 weeks (1 cycle) for a maximum of 6 cycles. Paclitaxel: Chloroquine 250mg po daily together with Paclitaxel (Taxane) 175 mg/m2 three hours infusion every three weeks. Docetaxel: Chloroquine 250mg po daily together with docetaxel 75 mg/m2 administered intravenously over one hour every three weeks Abraxane: Chloroquine 250mg po daily together with Abraxane 260 mg/m2 administered intravenously over 30 minutes every three weeks. Ixabepilone: Chloroquine 250mg po daily together with Ixabepilone is 40 mg/m2 administered intravenously over three hours every three weeks.
Age, Continuous	54.1 years n=93 Participants
Sex: Female, Male Female	38 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	3 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	6 Participants n=93 Participants
Race (NIH/OMB) White	29 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	38 Participants n=93 Participants
Metastatic breast cancer	23 Participants n=93 Participants
Locally advanced breast cancer	15 Participants n=93 Participants
HR+ HEGFR- breast cancer	20 Participants n=93 Participants
Triple Negative Breast Cancer	18 Participants n=93 Participants

PRIMARY outcome

Timeframe: 3-week cycles for maximum of 6 cycles (4.5 months)

Outcome measures

Outcome measures
Measure	Chloroquine With Taxane or Taxane-Like (Paclitaxel, Docetaxel, Abraxane, Ixabepilone) Chemotherapy n=31 Participants Chloroquine (250 mg) was given daily orally with either Paclitaxel or Docetaxel or Abraxane or Ixabepilone chemotherapy every 3 weeks (1 cycle) for a maximum of 6 cycles. Paclitaxel: Chloroquine 250mg po daily together with Paclitaxel (Taxane) 175 mg/m2 three hours infusion every three weeks. Docetaxel: Chloroquine 250mg po daily together with docetaxel 75 mg/m2 administered intravenously over one hour every three weeks Abraxane: Chloroquine 250mg po daily together with Abraxane 260 mg/m2 administered intravenously over 30 minutes every three weeks. Ixabepilone: Chloroquine 250mg po daily together with Ixabepilone is 40 mg/m2 administered intravenously over three hours every three weeks.
Overall Response Rate (ORR)	45.16 percentage of participants Interval 29.2 to 62.2

SECONDARY outcome

Timeframe: 25.4 months (median)

To assess the time to progression free survival of patients treated with the combination of Chloroquine and Taxane or Taxane-Like chemotherapy. Progression is defined as time from initiation of chemotherapy to disease progression 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", or similar definition as accurate and appropriate.

Outcome measures

Outcome measures
Measure	Chloroquine With Taxane or Taxane-Like (Paclitaxel, Docetaxel, Abraxane, Ixabepilone) Chemotherapy n=31 Participants Chloroquine (250 mg) was given daily orally with either Paclitaxel or Docetaxel or Abraxane or Ixabepilone chemotherapy every 3 weeks (1 cycle) for a maximum of 6 cycles. Paclitaxel: Chloroquine 250mg po daily together with Paclitaxel (Taxane) 175 mg/m2 three hours infusion every three weeks. Docetaxel: Chloroquine 250mg po daily together with docetaxel 75 mg/m2 administered intravenously over one hour every three weeks Abraxane: Chloroquine 250mg po daily together with Abraxane 260 mg/m2 administered intravenously over 30 minutes every three weeks. Ixabepilone: Chloroquine 250mg po daily together with Ixabepilone is 40 mg/m2 administered intravenously over three hours every three weeks.
Time to Progression Free Survival (PFS)	12.4 months Interval 4.9 to 24.6

SECONDARY outcome

Timeframe: a median of 25.4 months, up to 83.5 months

To assess the time of overall survival of patients receiving Chloroquine + Taxane or Taxane-like chemotherapy

Outcome measures

Outcome measures
Measure	Chloroquine With Taxane or Taxane-Like (Paclitaxel, Docetaxel, Abraxane, Ixabepilone) Chemotherapy n=31 Participants Chloroquine (250 mg) was given daily orally with either Paclitaxel or Docetaxel or Abraxane or Ixabepilone chemotherapy every 3 weeks (1 cycle) for a maximum of 6 cycles. Paclitaxel: Chloroquine 250mg po daily together with Paclitaxel (Taxane) 175 mg/m2 three hours infusion every three weeks. Docetaxel: Chloroquine 250mg po daily together with docetaxel 75 mg/m2 administered intravenously over one hour every three weeks Abraxane: Chloroquine 250mg po daily together with Abraxane 260 mg/m2 administered intravenously over 30 minutes every three weeks. Ixabepilone: Chloroquine 250mg po daily together with Ixabepilone is 40 mg/m2 administered intravenously over three hours every three weeks.
Time of Overall Survival (OS)	25.4 months Interval 13.7 to 83.5

SECONDARY outcome

Timeframe: 25.4 months (median)

To assess how many patients experienced grade 3 or greater adverse events when receiving the combination of Chloroquine and Taxane or Taxane-Like chemotherapy. Toxicity was assessed for all enrolled patients who received one or more doses of the study drug combination by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Outcome measures

Outcome measures
Measure	Chloroquine With Taxane or Taxane-Like (Paclitaxel, Docetaxel, Abraxane, Ixabepilone) Chemotherapy n=31 Participants Chloroquine (250 mg) was given daily orally with either Paclitaxel or Docetaxel or Abraxane or Ixabepilone chemotherapy every 3 weeks (1 cycle) for a maximum of 6 cycles. Paclitaxel: Chloroquine 250mg po daily together with Paclitaxel (Taxane) 175 mg/m2 three hours infusion every three weeks. Docetaxel: Chloroquine 250mg po daily together with docetaxel 75 mg/m2 administered intravenously over one hour every three weeks Abraxane: Chloroquine 250mg po daily together with Abraxane 260 mg/m2 administered intravenously over 30 minutes every three weeks. Ixabepilone: Chloroquine 250mg po daily together with Ixabepilone is 40 mg/m2 administered intravenously over three hours every three weeks.
Number of Patients Who Experienced Grade 3 of Greater Adverse Events	4 Participants

Adverse Events

Chloroquine With Taxane or Taxane-Like (Paclitaxel, Docetaxel, Abraxane, Ixabepilone) Chemotherapy

Serious events: 1 serious events

Other events: 9 other events

Deaths: 21 deaths

Serious adverse events

Serious adverse events
Measure	Chloroquine With Taxane or Taxane-Like (Paclitaxel, Docetaxel, Abraxane, Ixabepilone) Chemotherapy n=38 participants at risk Chloroquine (250 mg) was given daily orally with either Paclitaxel or Docetaxel or Abraxane or Ixabepilone chemotherapy every 3 weeks (1 cycle) for a maximum of 6 cycles. Paclitaxel: Chloroquine 250mg po daily together with Paclitaxel (Taxane) 175 mg/m2 three hours infusion every three weeks. Docetaxel: Chloroquine 250mg po daily together with docetaxel 75 mg/m2 administered intravenously over one hour every three weeks Abraxane: Chloroquine 250mg po daily together with Abraxane 260 mg/m2 administered intravenously over 30 minutes every three weeks. Ixabepilone: Chloroquine 250mg po daily together with Ixabepilone is 40 mg/m2 administered intravenously over three hours every three weeks.
Blood and lymphatic system disorders Neutropenia	2.6% 1/38 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed from time of informed consent up to 30 months. All-Cause Mortality was assessed up to 85 months and reported at a median follow-up of 25.36 months.

Other adverse events

Other adverse events
Measure	Chloroquine With Taxane or Taxane-Like (Paclitaxel, Docetaxel, Abraxane, Ixabepilone) Chemotherapy n=38 participants at risk Chloroquine (250 mg) was given daily orally with either Paclitaxel or Docetaxel or Abraxane or Ixabepilone chemotherapy every 3 weeks (1 cycle) for a maximum of 6 cycles. Paclitaxel: Chloroquine 250mg po daily together with Paclitaxel (Taxane) 175 mg/m2 three hours infusion every three weeks. Docetaxel: Chloroquine 250mg po daily together with docetaxel 75 mg/m2 administered intravenously over one hour every three weeks Abraxane: Chloroquine 250mg po daily together with Abraxane 260 mg/m2 administered intravenously over 30 minutes every three weeks. Ixabepilone: Chloroquine 250mg po daily together with Ixabepilone is 40 mg/m2 administered intravenously over three hours every three weeks.
Blood and lymphatic system disorders Thrombocytopenia	2.6% 1/38 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed from time of informed consent up to 30 months. All-Cause Mortality was assessed up to 85 months and reported at a median follow-up of 25.36 months.
Gastrointestinal disorders Diarrhea	2.6% 1/38 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed from time of informed consent up to 30 months. All-Cause Mortality was assessed up to 85 months and reported at a median follow-up of 25.36 months.
General disorders Back pain	2.6% 1/38 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed from time of informed consent up to 30 months. All-Cause Mortality was assessed up to 85 months and reported at a median follow-up of 25.36 months.
General disorders Dehydration	2.6% 1/38 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed from time of informed consent up to 30 months. All-Cause Mortality was assessed up to 85 months and reported at a median follow-up of 25.36 months.
General disorders Fatigue	5.3% 2/38 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed from time of informed consent up to 30 months. All-Cause Mortality was assessed up to 85 months and reported at a median follow-up of 25.36 months.
General disorders Infusion reaction	2.6% 1/38 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed from time of informed consent up to 30 months. All-Cause Mortality was assessed up to 85 months and reported at a median follow-up of 25.36 months.
General disorders Syncope	2.6% 1/38 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed from time of informed consent up to 30 months. All-Cause Mortality was assessed up to 85 months and reported at a median follow-up of 25.36 months.
General disorders Hand-foot syndrome	2.6% 1/38 • Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed from time of informed consent up to 30 months. All-Cause Mortality was assessed up to 85 months and reported at a median follow-up of 25.36 months.

Additional Information

Dr. Jenny Chang

Houston Methodist

Phone: 713-441-0681

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place