Liposomal Doxorubicin Before Mastectomy in Treating Women With Invasive Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Intraductal arm; Intravenous arm
Intervention description: Patients will receive PLD intraductally according to the dose escalation schema (Dose Level -1=1 mg, Dose Level 1=2 mg, Dose Level 2= 5mg, Dose Level 3=10 mg). The PLD dose will be diluted in 5% dextrose in water and will be mixed for a total volume of 5 ml. The PLD will be administered via a breast duct (i.e., intraductally) using a microcatheter; Blood samples and a breast tissue biopsy collected to look at levels of doxorubincol from patients receiving intravenous pegylated liposomal doxorubin to compare to the group receiving drug intraductally.
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIC breast cancer; stage IV breast cancer; breast cancer in situ; ductal breast carcinoma in situ

Summary:

      RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways
      to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving chemotherapy in different ways, such as into the breast ducts, may kill more
      tumor cells. Giving chemotherapy before surgery may make the tumor smaller and reduce the
      amount of normal tissue that needs to be removed.

      PURPOSE: This phase I trial is studying the side effects and best dose of liposomal
      doxorubicin when given before mastectomy in treating women with invasive breast cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed infiltrating carcinoma of the breast meeting any of the
             following criteria:

               -  T1-3, any N disease

               -  Proven ductal carcinoma in situ

          -  Unresected disease

               -  Planned mastectomy as definitive surgical procedure

                    -  Known or suspected metastatic disease allowed provided mastectomy is planned

          -  Nonpalpable tumor allowed (e.g., initial T2-3 tumor that responded to preoperative
             therapy)

          -  No inflammatory breast cancer or other T4 features

          -  Successful baseline ductogram

               -  Baseline nipple aspiration procedure must identify a duct productive of nipple
                  aspirate fluid

               -  No severe nipple retraction

          -  Hormone receptor status not specified

        PATIENT CHARACTERISTICS:

          -  Female patients

          -  Menopausal status not specified

          -  ECOG performance status 0-2

          -  Absolute neutrophil count ≥1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 9.0 g/dL

          -  Creatinine ≤ 2 times upper limit of normal (ULN)

          -  Bilirubin ≤ 2 times ULN

          -  AST and ALT ≤ 2.5 times ULN

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No significant history of severe allergy to iodinated contrast material or
             debilitating anxiety that may not allow for a ductogram

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  Prior preoperative chemotherapy, trastuzumab (Herceptin®), or hormonal therapy allowed
             provided it was completed 7-14 days prior to study treatment

          -  No prior radiation therapy, excisional biopsy, breast reduction, areolar surgery, or
             breast implant (present or past history of implant that was removed)

          -  No other prior procedure that may have altered the breast ductal system in the
             ipsilateral breast

          -  No other concurrent chemotherapy, radiotherapy, endocrine therapy, or biologic agents
             for breast cancer

          -  No other concurrent investigational drugs

          -  Concurrent bisphosphonates allowed