Phase II Study in Patients With Operable Breast Cancer

A Phase II Study of Pre-Operative Pegylated Liposomal Doxorubicin (PLD), Paclitaxel, and Trastuzumab in Patients With Operable Breast Cancer Over-expressing Her2-neu

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00518583

Enrollment

Registered

2007-08-20

Start date

2006-10-31

Completion date

2009-09-30

Last updated

2010-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast cancer, Over-expressing Her2-neu

Brief summary

The study will evaluate the safety and efficacy of the combination PLD, paclitaxel, and trastuzumab in patients with operable breast cancer. Patients will be treated with the combination for 18 weeks, followed by surgery.

Interventions

DRUGPegylated Liposomal Doxorubicin (Doxil)

Doxorubicin administered once every three weeks Taxol administered weekly Herceptin administered weekly

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

* Dx of clinical T1c-T3, N0-1, M0 breast cancer * Interval between diagnosis and consent of \<- 62 days * Life expectancy of 10 years * LVEF by MUGA \>= lower limit of normal for the testing facility * Negative serum pregnancy test * Adequate bone marrow, renal, liver function * Negative bone scan * HRT discontinued before study entry * Adequate contraceptive methods

Exclusion criteria

* Male breast cancer * Less than 21 years of age * Ulceration, infiltration of the skin, complete fixation or severe skin edema * N3 disease in which nodes are matted and fixed * Suspicious palpable supraclavicular nodes * CT evidence of malignant internal mammary nodes * Pregnancy or breast feeding at time of study entry * Prior therapy for breast cancer * Prior anthracycline for any malignancy * Prior breast malignancy of the contralateral breast * Prior non-breast malignancy within 5 years * Non-malignant disease that would preclude follow up * MI within 6 months, NYHA Class II or greater heart failure * Psychiatric disorders or conditions that would preclude provision of informed consent

Design outcomes

Primary

Measure	Time frame
Identify the pCR rate of neoadjuvant chemotherapy using the proposed 18-week regimen of PLD + paclitaxel + trastuzumab	within 18 weeks

Secondary

Measure	Time frame
Identify the complete response rate	within 18 weeks
Identify the partial response rate	within 18 weeks
Identify the overall response rate	within 18 weeks
Evaluate changes in cardiac function	within study participation
Monitor safety and tolerability of neoadjuvant chemotherapy using the proposed 18 week regimen	within study participation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026