International Journal of Clinical Oncology

, Volume 20, Issue 3, pp 480–489 | Cite as

Efficacy and safety of neoadjuvant chemotherapy with concurrent liposomal-encapsulated doxorubicin, paclitaxel and trastuzumab for human epidermal growth factor receptor 2-positive breast cancer in clinical practice

  • Joaquín GaviláEmail author
  • Ángel Guerrero
  • Miguel Ángel Climent
  • Aranzazu Fernández
  • Francisco Gozalbo
  • María Carrascosa
  • Josefina Camps
  • Vicente Guillem
  • Amparo Ruiz
Original Article



Based on previous results obtained with non-pegylated liposomal-encapsulated doxorubicin (TLC-D99) together with paclitaxel and trastuzumab in patients with human epidermal growth factor receptor 2 (HER2)-positive locally advanced or metastatic breast cancer (BC), a similar regimen was evaluated in the neoadjuvant setting in a prospectively selected series of consecutive patients with clinical stage II–III BC. Primary and secondary objectives included the rate of pathologic complete response (pCR), safety, and predictive factors of pCR.


Patients received six cycles of TLC-D99 (50 mg/m2 every 3 weeks), paclitaxel (80 mg/m2 weekly) and trastuzumab (4 mg/kg initial dose and 2 mg/kg weekly). All patients underwent surgery after treatment. pCR was defined as the absence of invasive cancer cells in the breast and the axilla.


Sixty-two patients with a median age of 46.6 years were analyzed. Stage IIIA was diagnosed in 43.5 % of patients and 14.5 % had inflammatory BC. Conservative surgery was performed in 46.8 % of the patients and pCR was achieved in 63 % (95 % CI 50.5–75.5). Patients with estrogen receptor (ER)-negative tumors presented a significantly higher pCR rate than patients with ER-positive tumors (74.4 vs 43.5 %; P = 0.028). Forty-five patients (72.6 %) completed study treatment and 80.6 % received at least five treatment cycles. No patients developed congestive heart failure and 14.5 % of patients showed a ≥10 % decrease in the left ventricular ejection fraction.


The triple combination therapy assessed is effective and safe, offering a high pCR rate in patients with HER2-positive BC.


Antibodies Breast neoplasm Drug therapy Prospective study Treatment outcome 



The authors thank HealthCo (Madrid, Spain) for assistance in the preparation of this manuscript. The financial support of this project was provided by Teva Pharma. Editorial assistance was provided by Mary Hines of inScience Communications, Springer Healthcare; this assistance was also funded by Teva Pharma.

Conflict of interest

The authors declare that they have no conflict of interest.


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Copyright information

© Japan Society of Clinical Oncology 2014

Authors and Affiliations

  • Joaquín Gavilá
    • 1
    • 5
    Email author
  • Ángel Guerrero
    • 1
  • Miguel Ángel Climent
    • 1
  • Aranzazu Fernández
    • 1
  • Francisco Gozalbo
    • 2
  • María Carrascosa
    • 3
  • Josefina Camps
    • 4
  • Vicente Guillem
    • 1
  • Amparo Ruiz
    • 1
  1. 1.Medical Oncology ServiceFundación Instituto Valenciano de OncologíaValenciaSpain
  2. 2.Pathological Anatomy ServiceFundación Instituto Valenciano de OncologíaValenciaSpain
  3. 3.Radiation Oncology ServiceFundación Instituto Valenciano de OncologíaValenciaSpain
  4. 4.Surgery ServiceFundación Instituto Valenciano de OncologíaValenciaSpain
  5. 5.Servicio de Oncología MédicaFundación Instituto Valenciano de OncologíaValenciaSpain

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