Know Cancer

forgot password

Phase II Open-Label Study of Preoperative Weekly Paclitaxel and Carboplatin With Lapatinib (Tykerb®) in Patients With ErbB2-Positive Stage I-III Breast Cancer

Phase 2
18 Years
Open (Enrolling)
ErbB2-Positive Stage I-III Breast Cancer

Thank you

Trial Information

Phase II Open-Label Study of Preoperative Weekly Paclitaxel and Carboplatin With Lapatinib (Tykerb®) in Patients With ErbB2-Positive Stage I-III Breast Cancer

- Pathologic complete response following neoadjuvant chemotherapy has been shown to be an
independent, strong predictor of disease-free and overall survival in operable breast

- The addition of neoadjuvant trastuzumab to chemotherapy results in a 2-3 fold increase
in pCR rates in operable ErbB2-positive breast cancer

- Lapatinib is being explored as an alternative to trastuzumab in large clinical trials
in operable ErbB2-positive breast cancer

- In a randomised phase III adjuvant trial, BCIRG 006, non-anthracycline chemotherapy
(docetaxel and carboplatin) has been shown to be as effective as conventional
sequential anthracycline-containing chemotherapy and docetaxel, in combination with
trastuzumab, but with improved cardiac safety

- Weekly paclitaxel has been shown in a randomized phase III study to be the optimal
adjuvant taxane regimen

- Weekly paclitaxel and carboplatin, in combination with lapatinib, has demonstrated
safety and efficacy in Phase I/II clinical studies of metastatic breast and ovarian

- The investigators aim to assess the efficacy of a non-anthracycline containing regimen,
weekly paclitaxel and carboplatin, in combination with lapatinib in inducing pCR in the
neoadjuvant treatment of ErbB2-positive non-metastatic breast cancer. The investigators
hypothesize that this combination will achieve pCR rates of at least 35%

Inclusion Criteria:

- • Female, Age ≥ 18 years

- Histologic or cytologic diagnosis of breast carcinoma

- T1-4 breast cancer with measurable primary breast tumor, defined as palpable
tumor with the largest diameter measuring 2.0cm or greater by calipers

- Tumor is HER2 positive either by IHC (3+) or FISH amplification (amplification
ratio >2.2)

- Patients must not have received prior chemotherapy or hormonal therapy for the
treatment of breast cancer

- Karnofsky performance status of 70 or higher

- Estimated life expectancy of at least 12 weeks

- Adequate organ function including the following:

Bone marrow:

- Absolute neutrophil (segmented and bands) count (ANC) >= 1.5 x 109/L

- Platelets >= 100 x 109/L


- Bilirubin <= 1.5 x upper limit of normal (ULN),

- ALT or AST <= 2.5x ULN


o Calculated creatinine clearance >30ml/minute

- Left ventricular ejection fraction >=50% measured by 2D echo or MUGA

- Signed informed consent from patient or legal representative

- Patient with reproductive potential must use an approved contraceptive method if
appropriate (e.g. intrauterine device, birth control pills, or barrier device) during
and for three months after the study. Females with childbearing potential must have a
negative serum pregnancy test within 7 days prior to study enrollment

Exclusion Criteria:

- • Prior treatment for locally advanced or metastatic breast cancer

- Treatment within the last 30 days with any investigational drug

- Concurrent administration of any other tumor therapy, including cytotoxic
chemotherapy, hormonal therapy, and immunotherapy

- Major surgery within 28 days of study drug administration

- Active infection that in the opinion of the investigator would compromise the
patient's ability to tolerate therapy

- Breast feeding

- Serious cardiac illness or medical conditions including but not confined to:

- History of documented congestive cardiac failure or systolic dysfunction
(LVEF <50%)

- High-risk uncontrolled arrhythmias (ventricular tachycardia, high-grade AV
block, supraventricular arrhythmias which are not adequately

- History of significant ischaemic heart disease

- Clinically significant valvular heart disease

- Poorly controlled hypertension (e.g. systolic BP > 180mmHg or diastolic

- Poorly controlled diabetes mellitus.

- Second primary malignancy that is clinically detectable at the time of
consideration for study enrollment.

- History of significant neurological or mental disorder, including seizures or

- Subjects who have current active hepatic or biliary disease (with exception of
patients with Gilbert's syndrome, asymptomatic gallstones or stable chronic
liver disease per investigator assessment)

- Concomitant use of CYP3A4 inhibitors

Type of Study:


Study Design:

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

Outcome Measure:

Rate of pathologic complete response

Outcome Time Frame:

12 weeks

Safety Issue:


Principal Investigator

Soo Chin Lee

Investigator Role:

Principal Investigator

Investigator Affiliation:

National University Hospital, Singapore


Singapore: Domain Specific Review Boards

Study ID:




Start Date:

April 2011

Completion Date:

December 2012

Related Keywords:

  • ErbB2-Positive Stage I-III Breast Cancer
  • Breast Neoplasms