CompletedPhase 3

Neo ALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) Study

Argentina455 participantsStarted 2008-01-05

Plain-language summary

This is a randomised, open label multicenter Phase III study comparing the efficacy of neoadjuvant lapatinib plus paclitaxel, versus trastuzumab plus paclitaxel, versus concomitant lapatinib and trastuzumab plus paclitaxel given as neoadjuvant treatment in HER2/ErbB2 over-expressing and/or amplified primary breast cancer. Patients will be randomised to receive either: lapatinib 1500 mg daily, trastuzumab 4 mg/kg intravenous (IV) load followed by 2 mg/kg IV weekly, or lapatinib 1000 mg daily with trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for a total of 6 weeks. After this biological window, patients on monotherapy arms will continue on the same targeted therapy plus weekly paclitaxel 80 mg/m\^2 for a further 12 weeks, up to definitive surgery. In the combination arm, patients will receive lapatinib 750 mg daily in combination with trastuzumab 2 mg/kg IV plus weekly paclitaxel 80mg/m\^2 IV for a further 12 weeks, up to definitive surgery. After surgery, patients will receive three courses of adjuvant chemotherapy with 5-Fluorouracil Epirubicin Cyclophosphamide (FEC) followed by the same targeted therapy as in the biological window of the neoadjuvant setting for a further 34 weeks (in the combination arm, lapatinib dose will be 1000 mg daily in combination with trastuzumab). The planned total duration of the anti-HER2 therapy one year. Primary objective is to evaluate and compare the rate of pathological complete response (pCR) at the time of surgery in patients with HER2/ErbB2 overexpressing or amplified operable breast cancer randomised to lapatinib followed by lapatinib plus paclitaxel versus trastuzumab followed by trastuzumab plus paclitaxel versus lapatinib in combination with trastuzumab followed by lapatinib, trastuzumab plus paclitaxel.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Female gender; * Age ≥18 years; * Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1 * Histologically confirmed invasive breast cancer: * Primary tumour greater than 2 cm diameter, measured by clinical examination and mammography or echography, * Any N, * No evidence of metastasis (M0) (isolated supraclavicular node involvement allowed); * Over expression and/or amplification of HER2 in the invasive component of the primary tumour \[Wolff et al 2006\] and confirmed by a certified laboratory prior to randomisation * Known hormone receptor status. * Haematopoietic status: * Absolute neutrophil count ≥ 1,5 x 10\^9/L, * Platelet count ≥ 100 x 10\^9/L, * Hemoglobin at least 9 g/dl, * Hepatic status: * Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN). In the case of known Gilbert's syndrome, a higher serum total bilirubin (\< 2 x ULN) is allowed, * Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 times ULN, * Alkaline phosphatase ≤ 2.5 times ULN, * Renal status: * Creatinine ≤ 2.0 mg/dL, * Cardiovascular: * Baseline left ventricular ejection fraction (LVEF) ³ 50% measured by echocardiography (ECHO) or Multiple Gate Acquisition (MUGA) scan, * Negative serum pregnancy test, within 2-weeks (preferably 7 days) prior to randomization (For women of childbearing potential) * Fertile patients must use effective contraception (barrier method - condoms, diaphragm - also in conjunction with spermicidal jelly, or total abs…

What they're measuring

Number of Participants With Pathological Complete Response (pCR) at the Time of Surgery

Timeframe: Weeks 20 to 22

Trial details

NCT IDNCT00553358

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-05-27

Results submitted2011-05-26