A Phase I-II Study of Lapatinib and docetaxel as neoadjuvant treatment for HER-2 positive locally advanced/inflammatory or large operable breast cancer
- Conditions
- ocally advanced/inflammatory or large operable breast cancerMedDRA version: 8.1 Level: LLT Classification code 10021974 Term: Inflammatory breast cancer
- Registration Number
- EUCTR2006-000864-94-FR
- Lead Sponsor
- European Organisation for Research and Treatment of Cancer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 128
Female patients with locally advanced or inflammatory breast cancer for whom neo-adjuvant chemotherapy is appropriate defined as:
? Clinical T4 a,b,c,d, any N (inflammatory breast carcinoma: tumor mass, breast
enlargement, oedema and warmth of the skin are often present but not mandatory
for the diagnosis)
? Or any clinical T, N2 or N3 (ipsilateral supraclavicular nodes)
? Presence of bilateral breast cancer is allowed
? Patients with minimal lung, skin, or nodal metastatic disease shall be discussed case-by-case with the study co-ordinators. Patients with bone, liver or other extensive metastases are non eligible
? No prior therapy for any cancer, including chemotherapy, radiotherapy, hormonotherapy for
breast cancer, EGFR or HER-2 or antibody therapy.
? Histologically confirmed diagnosis of invasive breast cancer
? Known hormone receptor status: ER/PR positive or negative.
? HER-2 positive (IHC 3+, or IHC 2+ and FISH/CISH +, or FISH, or CISH+ only)
? Two frozen trucuts with a 14 G needle are mandatory for every core biopsy indicated by the translational research study
? Age 18 to 70 years
? WHO performance status 0-2
? Adequate bone marrow function: hemoglobin > 10.0 g/dl or 6.2 mmol/L, neutrophils > 1.5 x 109/L and platelets > 100 x 109/L
? Adequate hepatic and renal function, defined as follows:
? Bilirubin < 1.5 x ULN,
? AST and/or ALT < 3 x ULN
? Serum creatinine < 1.5 x ULN
? Patients must be accessible for repeat dosing and follow-up
? Clinically normal cardiac function (LVEF assessed by MUGA or ECHO), normal 12 lead ECG, and in the past 6 months no serious cardiac illness or medical condition including but not confined to:
EORTC 10054 Phase I-II LAPATAX LABC
Version 1.1 22 / 123 26 July, 2006
? History of documented congestive heart failure (CHF)
? High-risk uncontrolled arrhythmias
? Angina pectoris requiring antianginal medication
? Clinically significant valvular heart disease
? Evidence of transmural infarction on ECG
? Poorly controlled hypertension (e.g. systolic >180mm Hg or diastolic greater
than 100mm Hg)
? Drugs and several HERBAL CONSTITUENTS (e.g. bergamottin and glabridin), which are inducers or inhibitors of CYP3A4 must not be taken within 10 days prior to initiation of treatment and are prohibited while the patient is being treated with Lapatinib (a detailed list is provided in chapter 5)
? No clinical signs of CNS involvement
? Women should either not be of childbearing potential (having had a hysterectomy, a bilateral oophorectomy or bilateral tubal ligation, or be post-menopausal with a total cessation of menses of > 1 year), or not be pregnant (negative serum pregnancy test at entry); should not be lactating; should agree to use contraceptive methods (with a documented failure rate < 1%, vasectomized partner sterile prior to trial entry and sole sexual partner or double-barrier contraception) while on treatment and during a period of 3 months after the end of treatment.
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method