Neoadjuvant Pegylated Liposomal Doxorubicin and Cyclophosphamide +/- Trastuzumab Followed by Docetaxel in Breast Cancer

A Phase II Study of Neoadjuvant Treatment With Pegylated Liposomal Doxorubicin (Caelyx) and Cyclophosphamide +/- Trastuzumab Followed by Docetaxel in Patients With Locally Advanced Breast Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01206881

Enrollment

Registered

2010-09-22

Start date

2009-03-31

Completion date

2011-06-30

Last updated

2011-07-04

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, neoadjuvant, liposomal doxorubicin, PET scan

Brief summary

The purpose of this study is to determine the efficacy of neoadjuvant treatment with pegylated liposomal doxorubicin (Caelyx) and cyclophosphamide +/- trastuzumab followed by docetaxel in patients with locally advanced, inflammatory breast cancer or with a primary tumor \> 5 cm.

Detailed description

Patients with locally advanced or inflammatory breast cancer have a very bad prognosis. Several studies have shown that patients who receive a pathological complete response have the best prognosis. Neoadjuvant chemotherapy including anthracyclines and taxanes has become established as a standard option in the multidisciplinary management of this group of patients. In HER2 positive patients, chemotherapy in combination with trastuzumab is therapeutically attractive. Recent studies have also demonstrated that evaluation with PET-CT scan can be used to stratify treatment and monitor early response to neoadjuvant therapy.

Interventions

DRUGpegylated liposomal doxorubicin

35 mg/m2, IV, day 1 every 21 days, 4 cycles

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* pathologically proven breast cancer * inflammatory, locally advanced breast cancer or a tumor \> 5 cm * ECOG performance status \< 2 * LVEF \> 50% measured by MUGA (HER2 positive patients) * adequate bone marrow, liver and renal function * written informed consent must be obtained

Exclusion criteria

* another malignancy within 5 years prior to study entry * concurrent treatment with an investigational agent * other disease or condition that contraindicates participation in the study * pregnant or lactating females

Design outcomes

Primary

Measure	Time frame	Description
clinical response rate	24 weeks	evaluation of treatment efficacy every 2.cycle

Secondary

Measure	Time frame
pathological response rate, response rate as defined by PET-CT scan, mammography and ultrasound, evaluation of toxicity of the combination regimen	up to 30 weeks

Countries

Denmark

Outcome results

None listed

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