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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01206881
• Other study ID #: PO5903, EudraCT 2008-007951-29
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2010
• Last updated: June 30, 2011
• Start date: March 2009
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• pegylated liposomal doxorubicin
35 mg/m2, IV, day 1 every 21 days, 4 cycles

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
Denmark	Rigshospitalet	Copenhagen
Denmark	Herlev Hospital	Herlev
Denmark	Odense University Hospital	Odense

Sponsors (4)

Lead Sponsor	Collaborator
Herlev Hospital	Aarhus University Hospital, Odense University Hospital, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical response rate	evaluation of treatment efficacy every 2.cycle	24 weeks	No
Secondary	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	Yes