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NCT Number: NCT01206881

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Aarhus University Hospital, Aarhus, Denmark

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pegylated liposomal doxorubicin

Drug

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

Other names: cyclophosphamide, 4 cycles, docetaxel, 4 cycles, trastuzumab, 8 cycles

Primary outcomes

  1. clinical response rate

    Time frame: 24 weeks

    evaluation of treatment efficacy every 2.cycle

Secondary outcomes

  1. pathological response rate, response rate as defined by PET-CT scan, mammography and ultrasound, evaluation of toxicity of the combination regimen

    Time frame: up to 30 weeks

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Collaborators

  • Aarhus University Hospital
  • Odense University Hospital
  • Rigshospitalet, Denmark

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 22, 2010
Registry last updated
Jul 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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