Pegylated Liposomal Doxorubicin and Docetaxel in Treating Women With Locally Advanced Breast Cancer That Can Be Removed By Surgery
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: docetaxel; pegylated liposomal doxorubicin hydrochloride; conventional surgery; neoadjuvant therapy
Intervention MeSH terms: Docetaxel; Doxorubicin; Liposomal doxorubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Enrollment: 6.0
Sex: Female
Maximum age: 64 Years
Healthy volunteers: No
Keywords: stage IIIA breast cancer; stage IIIB breast cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin 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) and giving them
      before surgery may kill more tumor cells.

      PURPOSE: This phase II trial is studying the side effects of giving liposomal doxorubicin
      together with docetaxel before surgery and to see how well it works in treating women with
      locally advanced breast cancer that can be removed by surgery.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed breast cancer using core biopsies

               -  Locally advanced disease

               -  Resectable disease

               -  Fine needle aspiration cytology allowed and must demonstrate invasive
                  adenocarcinoma

          -  No more than 8 weeks since initial cytologic or histologic diagnosis of breast cancer

          -  Tumor must meet the following criteria:

               -  Palpable on clinical examination and confined to either the breast or to the
                  breast and ipsilateral axilla

               -  Measured clinically as greater than 2 cm in size (T2)

          -  Patients with skeletal pain are eligible if bone scan and/or roentgenological
             examination fail to disclose metastatic disease

               -  Suspicious findings must be confirmed as benign by x-ray, MRI scan, or biopsy

          -  Hormonal status not specified

        PATIENT CHARACTERISTICS:

        Inclusion criteria:

          -  Female

          -  Menopausal status not specified

          -  ECOG performance status 0-2

          -  Life expectancy ≥ 10 years

          -  Platelet count ≥ 100,000/mm³

          -  ANC ≥ 1,500/mm³

          -  Hemoglobin ≥ 9.0 g/dL

          -  Bilirubin normal

          -  AST or ALT normal

          -  Alkaline phosphatase normal

          -  Serum creatinine normal

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception (e.g., abstinence, intrauterine
             device, barrier device with spermicide, or surgical sterilization) during and for 3
             months after completion of study therapy

          -  Normal cardiac function by LVEF or MUGA scan

          -  Patients with prior non-breast malignancies are eligible if they have been
             disease-free for ≥ 10 years

               -  The following are allowed even if diagnosed within the past 10 years:

                    -  Squamous or basal cell carcinoma of the skin that has been effectively
                       treated

                    -  Carcinoma in situ of the cervix that has been treated by operation only

                    -  Lobular carcinoma in situ of the ipsilateral or contralateral breast treated
                       by segmental resection only

        Exclusion criteria:

          -  Pregnant or lactating women

          -  Male patients

          -  Hyperbilirubinemia

          -  Female patients with 1 or more of the following conditions:

               -  Ulceration, erythema, infiltration of the skin (complete fixation), or peau
                  d'orange (edema) of any magnitude

                    -  Tethering or dimpling of the skin or nipple inversion should not be
                       interpreted as skin infiltration

               -  Ipsilateral lymph nodes that are clinically fixed to one another or to other
                  structures (N2 disease)

               -  Bilateral malignancy or a mass in the opposite breast suspicious for malignancy,
                  unless there is biopsy proof that the mass is not malignant

               -  Suspicious palpable nodes in the contralateral axilla or palpable supraclavicular
                  or infraclavicular nodes, unless there is biopsy evidence that these are not
                  involved with the tumor

          -  Nonmalignant systemic disease (e.g., cardiovascular, renal, or hepatic) that would
             preclude study therapy

          -  Active cardiac disease that would preclude the use of doxorubicin hydrochloride,
             including any of the following:

               -  Documented myocardial infarction

               -  Angina pectoris that requires the use of antianginal medication

               -  History of documented New York Heart Association class II-IV heart failure

               -  Valvular disease with documented cardiac function compromise

               -  Poorly controlled hypertension (i.e., diastolic BP > 100 mm Hg)

                    -  Patients with well-controlled hypertension and on medication are eligible
                       for study

          -  Psychiatric or addictive disorders that would preclude obtaining informed consent

        PRIOR CONCURRENT THERAPY:

        Inclusion criteria:

          -  Concurrent noncancer therapies allowed if used for conditions other than breast cancer

          -  Adjuvant therapy after surgery allowed

        Exclusion criteria:

          -  Prior radiotherapy, chemotherapy, immunotherapy, and/or hormonal therapy for breast
             cancer

          -  Prior anthracycline therapy for any condition

          -  Concurrent hormonal therapy including tamoxifen, aromatase inhibitors, or raloxifene

          -  Concurrent sex hormonal therapy including birth-control pills or ovarian hormonal
             replacement therapy

          -  Concurrent other cancer therapy

          -  Concurrent herbal or alternative therapies for breast cancer