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NCT01446016 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by The Methodist Hospital Research Institute.

Completed
Registry status
Phase 2
Development phase
38
Enrollment target

NCT01446016: Completed Phase 2 study, sponsored by The Methodist Hospital Research Institute.

NCT01446016 is a Phase 2 study that has completed, run by The Methodist Hospital Research Institute. The registered enrollment target is 38 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01446016, a Phase 2 study, has completed, sponsored by The Methodist Hospital Research Institute.

COMPLETED
Registry status
Phase 2
Development phase
38 participants
Enrollment target

Study 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).

Primary Outcome

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

Interventions

  • DRUG Docetaxel
  • DRUG Paclitaxel
  • DRUG Abraxane
  • DRUG Ixabepilone

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2011-09
Est. Completion 2019-03-01
Phase Phase 2

What the finished NCT01446016 record still lists

NCT01446016 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).

The record links to 0 conditions, and to 4 interventions - of which Docetaxel is the first listed.

NCT01446016 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01446016 about?

NCT01446016 is a clinical study titled "Chloroquine With Taxane Chemotherapy for Advanced or Metastatic Breast Cancer After Anthracycline Failure (CAT)". 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 breas...

What is the current status of trial NCT01446016?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2011-09. Estimated completion is 2019-03-01.

What interventions are being tested in trial NCT01446016?

The interventions under investigation include: Docetaxel (DRUG), Paclitaxel (DRUG), Abraxane (DRUG), Ixabepilone (DRUG).

Who is sponsoring clinical trial NCT01446016?

This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01446016's enrollment target sits among peer trials

38 1467th of 2000 higher than 517 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01446016, the US trial registry maintained by the National Library of Medicine. NCT01446016 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.