Clinical trial NCT01206881: Neoadjuvant Pegylated Liposomal Doxorubicin and Cyclophosphamide +/- Trastuzumab Followed by Docetaxel in Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: breast cancer
neoadjuvant
liposomal doxorubicin
PET scan
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: Odense University Hospital
name: Aarhus University Hospital
First posted: 2010-09-22
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: clinical response rate
timeFrame: 24 weeks
Secondary outcomes:
measure: pathological response rate, response rate as defined by PET-CT scan, mammography and ultrasound, evaluation of toxicity of the combination regimen
timeFrame: up to 30 weeks
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Herlev Hospital, Department of Oncology
name: Malgorzata K Tuxen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Ulla B Tange, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Odense University Hospital
name: Soeren Cold, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Herlev Hospital
name: Susanne B Søndergaard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Odense University Hospital
name: Henrik Petersen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarhus University Hospital
name: Inger Hoejris, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarhus University Hospital
name: Anni Eskild-Jensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.