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Evaluate Trastuzumab Plus Standard Chemotherapy Given Before Surgery in Breast Cancer Patients With Low HER 2 Expression

This study is ongoing, but not recruiting participants.
Celgene Corporation
Information provided by (Responsible Party):
University of Kansas Medical Center Identifier:
First received: July 16, 2009
Last updated: January 20, 2017
Last verified: January 2017
The purpose of this study is to find out if there is a benefit of adding Herceptin (trastuzumab) to standard chemotherapy in this type of breast cancer.

Condition Intervention Phase
Breast Cancer
Drug: nab-paclitaxel
Drug: trastuzumab
Drug: Doxorubicin
Drug: cyclophosphamide
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Abraxane and Trastuzumab Followed by Dose Dense Doxorubicin and Cyclophosphamide as Neoadjuvant Therapy in Invasive Breast Cancer With Low HER2 Expression (1+ or 2+ by IHC)

Resource links provided by NLM:

Further study details as provided by University of Kansas Medical Center:

Primary Outcome Measures:
  • Pathologic Complete Response [ Time Frame: 22 weeks ]

Secondary Outcome Measures:
  • Assessment of cardiac safety by comparing left ventricular ejection fraction by echocardiogram from baseline to completion of treatment and assessment of reduction in primary tumor size response after first two cycles of chemotherapy with pCR rate. [ Time Frame: 22 weeks ]

Estimated Enrollment: 30
Study Start Date: July 2009
Estimated Study Completion Date: April 2017
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Nab-paclitaxel, trastuzumab, doxorubicin, cyclophosphamide
Drug: nab-paclitaxel
100 MG/M2 IV over 30 minutes once a week for 12 weeks
Other Name: Abraxane
Drug: trastuzumab
4 MG loading dose followed by 2 MG/KG every week for a total of 12 weeks
Other Name: Herceptin
Drug: Doxorubicin
60 MG/M2 every two weeks for a total of 4 cycles
Other Name: Adriamycin
Drug: cyclophosphamide
600 MG/M2 every 2 weeks for 4 cycles (administered with Doxorubicin above)
Other Name: Cytoxan

Detailed Description:

Neoadjuvant (primary) chemotherapy refers to chemotherapy given before surgery. Neoadjuvant chemotherapy has a number of potential advantages including increasing the chances for breast preservation at the time of surgery as well as it may improve the local control of the cancer. Several national breast cancer studies have shown that neoadjuvant chemotherapy was equal to chemotherapy given following surgery.

A standard treatment for stage II or Stage III invasive breast cancer with low HER2 expression is combination chemotherapyAdriamycin, Cytoxan,followed by a Taxane: given either before or after surgery), followed by surgery +/- radiation therapy.

The main purpose of chemotherapy however is to reduce the risk of recurrence of cancer and also make surgery more successful. HER2 is a receptor located on the surface of some cells. This receptor plays a role in regulating the growth of the cell, in addition to the growth of tumors. High levels of the HER2 receptor may predict those women who benefit from treatment with agents such as Herceptin that target HER2. Herceptin (Trastuzumab) is a drug that is effective both alone and in combination with standard chemotherapy. There is some data to suggest that patients whose tumors have low expression of the HER2 protein and are normal by FISH may also receive benefit from Herceptin.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Female patient ≥ 18 years of age
  • Histologically proven stage II or III adenocarcinoma of the breast
  • Must be candidate for neoadjuvant treatment (Tumor size ≥ 2 cm, T2, T3, T4 and/or clinical N1 or N2).
  • HER-2/neu 1+ or 2+ by immunohistochemistry
  • Must have operable tumor.
  • Performance status of 2 or better per SWOG criteria
  • LVEF ≥ 55% by echocardiogram performed within 4 weeks prior to treatment initiation
  • If patient of childbearing potential, pregnancy test is negative
  • Patients with reproductive potential must use an effective method to avoid pregnancy for the duration of the trial.
  • Adequate bone marrow function: ANC > 1500/mm3, platelet count > 100,000/mm3, and hemoglobin > 9 g/dL
  • Adequate kidney function: serum creatinine of < 1.5mg/dl and/or creatinine clearance of > 60 mL/min
  • Adequate hepatic function: transaminases < 2.5 x upper limit of normal and total bilirubin < 1.5 mg/dL
  • Must be informed of the investigational nature of the study and must sign an informed consent in accordance with the institutional rules.
  • Pretreatment lab values must be performed within 14 days of patient registration, and other baseline studies (with the exception of mammogram) must be performed within 30 days of patient registration.


  • Patient with metastatic breast cancer.
  • Women with tumors that are HER-2 neu 0+ or 3+ by immunohistochemistry
  • Women with HER 2 FISH amplified tumors (FISH ratio >2.2)
  • Patients who have had prior endocrine therapy for > 4 weeks or chemotherapy for this breast cancer will be excluded.
  • Locally advanced, inoperable tumors will be excluded.
  • The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of drugs in this protocol or place the subject at undue risk for treatment complications.
  • History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias
  • Ejection fraction < 55%
  • Pregnancy or lactation
  • Patients with inadequate laboratory values (as defined above) are excluded from study.
  • Patients with NCI common toxicity criteria (CTC) grade 2 or greater peripheral neuropathy are excluded from study.
  • Patients with active infection are excluded from study.
  • Patients with concomitant or previous malignancies within the last 5 years, are excluded from the study. Exceptions include: adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and ductal carcinoma in situ (DCIS).
  • Patients with emotional limitations are excluded from study.
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Please refer to this study by its identifier: NCT00944047

United States, Kansas
Hays Medical Center
Hays, Kansas, United States, 67601
University of Kansas Medical Center Cancer Center
Kansas City, Kansas, United States, 66205
Sponsors and Collaborators
University of Kansas Medical Center
Celgene Corporation
Principal Investigator: Qamar Khan, MD University of Kansas Medical Center Cancer Center
  More Information

Responsible Party: University of Kansas Medical Center Identifier: NCT00944047     History of Changes
Other Study ID Numbers: 11368
Study First Received: July 16, 2009
Last Updated: January 20, 2017

Keywords provided by University of Kansas Medical Center:
invasive breast cancer
primary breast cancer
neo-adjuvant therapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Liposomal doxorubicin
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors processed this record on April 26, 2017