Conditions: Breast Cancer
Keywords: stage II breast cancer stage IIIC breast cancer inflammatory breast cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 41
Healthy volunteers: no

Brief summary:
RATIONALE: Oxidized glutathione (NOV-002) may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving NOV-002 together with chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving oxidized glutathione (NOV-002) together with doxorubicin and cyclophosphamide followed by docetaxel works in treating women with newly diagnosed stage II or stage III breast cancer.

Detailed description:
OUTLINE: This is a multicenter study.

Patients receive oxidized glutathione (NOV-002) IV twice on day -1 of course 1 and once on day 1 of courses 2-8. Patients receive NOV-002 subcutaneously once daily on days 2-21 of courses 1-8. Patients also receive chemotherapy comprising doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 of courses 1-4 followed by docetaxel IV on day 1 of courses 5-8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Patients undergo definitive surgery 3-6 weeks after completion of neoadjuvant therapy.

Blood samples are obtained at baseline and periodically during study to measure serum and plasma protein glutathionlylation. Additional blood samples are collected from some patients for immunological correlative studies.

After completion of study therapy, patients are followed at 30 days.

Arms:
arm 1: * NOV-002:

  * Cycle 1, Day -1 only: 60 mg intravenously (IV) x 2, 3 hours (+/- 30 minutes) apart
  * Cycles 1 - 8, Day 1: 60 mg IV, 1 hour (+/- 30 minutes) prior to chemotherapy administration
  * Cycle 1 - 8, Days 2 - 21: 60 mg subcutaneous injections
* Cyclophosphamide: 600 mg/m2 IV, Cycles 1 - 4, Day 1
* Doxorubicin: 60 mg/m2 IV, Cycles 1 - 4, Day 1
* Docetaxel: 100 mg/m2 IV, Cycles 5 - 8, Day 1

Interventions: intervention 1: Cyclophosphamide intervention 2: Docetaxel intervention 3: Doxorubicin intervention 4: NOV 002
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol document: