Breast Cancer Clinical Trial

Pegylated Liposomal Doxorubicin and Docetaxel in Treating Women With Locally Advanced Breast Cancer That Can Be Removed By Surgery

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.

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Full Description

OBJECTIVES:

Primary

To evaluate the rate of pathological complete response and clinical complete response in women with locally advanced breast cancer treated with pegylated doxorubicin hydrochloride liposome and docetaxel.

Secondary

To assess the overall clinical local regional response in patients treated with this preoperative chemotherapy regimen.
To evaluate the number of patients who would have required a mastectomy upfront but who underwent breast conservation therapy instead after neoadjuvant chemotherapy.
To assess the safety, particularly with regard to neutropenia and cardiac toxicity, of pegylated doxorubicin hydrochloride liposome and docetaxel.

OUTLINE: This is a multicenter study.

Patients receive pegylated doxorubicin hydrochloride liposome IV over 90 minutes and docetaxel IV over 90 minutes on day 1. Patients receive pegylated filgrastim subcutaneously on days 2 or 3 post-chemotherapy in courses 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Within 8 weeks after completion of chemotherapy, patients undergo a lumpectomy or mastectomy to remove the tumor. Some patients may receive additional therapy after surgery, including hormonal therapy, chemotherapy, or radiotherapy.

After completion of study therapy, patients are followed periodically for up to 5 years.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

6

Study ID:

NCT00524459

Recruitment Status:

Terminated

Sponsor:

Roswell Park Cancer Institute

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There is 1 Location for this study

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Roswell Park Cancer Institute
Buffalo New York, 14263, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

6

Study ID:

NCT00524459

Recruitment Status:

Terminated

Sponsor:


Roswell Park Cancer Institute

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