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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


Phase 2
18 Years
75 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

clinical response rate

Outcome Description:

evaluation of treatment efficacy every 2.cycle

Outcome Time Frame:

24 weeks

Safety Issue:

No

Principal Investigator

Malgorzata K Tuxen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Herlev Hospital, Department of Oncology

Authority:

Denmark: Ethics Committee

Study ID:

PO5903, EudraCT 2008-007951-29

NCT ID:

NCT01206881

Start Date:

March 2009

Completion Date:

June 2011

Related Keywords:

  • Breast Cancer
  • breast cancer
  • neoadjuvant
  • liposomal doxorubicin
  • PET scan
  • Breast Neoplasms

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