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A Phase I, Open-label, Study of the Safety and Tolerability of Cyclosporine A (CsA) in Combination With Nab-paclitaxel in Patients With Metastatic Breast Cancer

Phase 1
18 Years
Open (Enrolling)
Metastatic Breast Cancer

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Trial Information

A Phase I, Open-label, Study of the Safety and Tolerability of Cyclosporine A (CsA) in Combination With Nab-paclitaxel in Patients With Metastatic Breast Cancer

Treatment for metastatic breast cancer commonly involves the use of the chemotherapy drug
nab-paclitaxel. Nab-paclitaxel is a special preparation of paclitaxel inside a protein
layer of albumin. Other studies have shown Cyclosporine A (CsA) may block the progression
of advanced breast cancer. The combination of nab-paclitaxel and CsA is considered
investigational which means it has not been approved by the US Food and Drug Administration,
FDA. Participants on this study will receive nab-paclitaxel through a vein in the arm weekly
3 weeks out of 4, in the outpatient clinic. On the same day as the first infusion of
nab-paclitaxel, participants will begin taking CsA tablets twice a day by mouth.
Participants will continue to receive study treatment as long as their tumor responds. If
the tumor does not respond or the participant experience severe side effects from study
treatment, she will be removed from the study and offered other therapies, if that is

Inclusion Criteria

Inclusion Criteria

- Female or male patients with adenocarcinoma of the breast with metastatic disease.

- Patients may have evaluable or measurable disease.

- Age > 18 years.

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control or abstinence) prior to study entry and
for the duration of study participation. Should a woman become pregnant or suspect
she is pregnant while participating in this study, she should inform her treating
physician immediately.

- Able to swallow and retain oral medication.

Exclusion Criteria

- Patients who have had any major surgery, hormonal therapy (other than replacement),
chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C)
prior to entering the study or patients who have not recovered from adverse events
due to agents administered more than 4 weeks earlier. Prior nab-paclitaxel is

- Patients may not be receiving any other investigational agents or receiving
concurrent anticancer therapy.

- Patients with uncontrolled brain metastases or leptomeningeal disease or active
neurologic impairment.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to Cyclosporine A or nab-paclitaxel.

- Pregnant or lactating (Cyclosporine A is excreted into breast milk) females

- Patients with GI tract disease resulting in an inability to take oral medication,
malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures
affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative

- HIV-positive patients are excluded since Cyclosporine A may result in further

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the safety, tolerability and feasibility of the combination of Cyclosporine A and nab-paclitaxel in the treatment of metastatic breast cancer (MBC).

Outcome Time Frame:

labs drawn weekly

Safety Issue:


Principal Investigator

Mary Cianfrocca, DO

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University


United States: Institutional Review Board

Study ID:

NU 08B7



Start Date:

February 2010

Completion Date:

February 2016

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Cancer
  • Breast Neoplasms



Northwestern University, Northwestern Medical Faculty Foundation Chicago, Illinois  60611-3013