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Phase II Study of Neoadjuvant Pegylated Liposomal Doxorubicin and Docetaxel in Locally Advanced Operable Breast Cancer

Phase 2
64 Years
Not Enrolling
Breast Cancer

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Trial Information

Phase II Study of Neoadjuvant Pegylated Liposomal Doxorubicin and Docetaxel in Locally Advanced Operable Breast Cancer



- 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.


- 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.

Inclusion Criteria


- Histologically or cytologically confirmed breast cancer using core biopsies

- Locally advanced disease

- Resectable disease

- Fine needle aspiration cytology allowed and must demonstrate invasive

- 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


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

- 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


Inclusion criteria:

- Concurrent noncancer therapies allowed if used for conditions other than breast

- Adjuvant therapy after surgery allowed

Exclusion criteria:

- Prior radiotherapy, chemotherapy, immunotherapy, and/or hormonal therapy for breast

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Primary Purpose: Treatment

Outcome Measure:

Pathological complete response

Safety Issue:


Principal Investigator

Tracey O'Connor, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Federal Government

Study ID:

I 75506



Start Date:

May 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • Breast Neoplasms



Roswell Park Cancer Institute Buffalo, New York  14263