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

NCT ID: NCT01206881

Last Updated: 2011-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2011-06-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

pegylated liposomal doxorubicin

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

Intervention Type: DRUG

Other Intervention Names

cyclophosphamide, 4 cycles; docetaxel, 4 cycles; trastuzumab, 8 cycles

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

Herlev Hospital

OTHER

Sponsor Role: lead

Responsible Party

Department of Oncology, Herlev Hospital

Principal Investigators

Malgorzata K Tuxen, MD

Role: PRINCIPAL_INVESTIGATOR

Herlev Hospital, Department of Oncology

Ulla B Tange, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Soeren Cold, MD

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Susanne B Søndergaard, MD

Role: PRINCIPAL_INVESTIGATOR

Herlev Hospital

Henrik Petersen, MD

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Inger Hoejris, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Anni Eskild-Jensen, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

Aarhus University Hospital

Aarhus, , Denmark

Rigshospitalet

Copenhagen, , Denmark

Herlev Hospital

Herlev, , Denmark

Odense University Hospital

Odense, , Denmark

Countries

Denmark

References

Tuxen MK, Cold S, Tange UB, Balslev E, Nielsen DL. Phase II study of neoadjuvant pegylated liposomal doxorubicin and cyclophosphamide +/- trastuzumab followed by docetaxel in locally advanced breast cancer. Acta Oncol. 2014 Oct;53(10):1440-5. doi: 10.3109/0284186X.2014.921727. Epub 2014 Jul 3. No abstract available.

Reference Type: DERIVED

PMID: 24991893 (View on PubMed)

Other Identifiers

PO5903, EudraCT 2008-007951-29

Identifier Type: -

Identifier Source: org_study_id