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

NCT00524459 | Terminated Phase 2 Results DMC

• 2 other identifiers: I 75506RPCI-I-75506
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

stage IIIA breast cancer; stage IIIB breast cancer

Outcome Measures

Primary Outcomes (2)

• Pathological Complete Response

  Mammogram done pre-treatment and after four and six cycles of study chemotherapy treatment.

• Clinical Complete Response

  Surgery done after completion of six cycles of study chemotherapy treatment.

Secondary Outcomes (3)

• Overall Clinical Local Regional Response

  Mammogram done pre-treatment and after four and six cycles of study chemotherapy treatment.

• Number of Women Who Would Have Required a Mastectomy Upfront But Who Underwent Breast Conservation Therapy Instead After Neoadjuvant Chemotherapy

  Baseline (pre-treatment) surgical assessment, and post-chemotherapy surgical outcome.

• Safety, in Terms of Neutropenia and Cardiac Toxicity

  Every cycle during study treatment and 8 weeks post-treatment.

Interventions

docetaxel DRUG

pegylated liposomal doxorubicin hydrochloride DRUG

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

Eligibility Criteria

• Age: Up to 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Combined Modality Therapy; Therapeutics

Limitations and Caveats

Due to the study's early termination and inadequate number of patients, no patients were analyzed.

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

716-845-2300

Study Officials

• Tracey O'Connor, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2007
• First Posted: September 3, 2007
• Study Start: May 1, 2007
• Primary Completion: August 1, 2008
• Last Updated: August 29, 2014
• Results First Posted: August 22, 2014

Record last verified: 2014-08

Locations

US (1)