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Spots Global Cancer Trial Database for Neo ALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) Study

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Trial Identification

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

Official Title: Neo ALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) Study: A Randomised, Multicenter Open-label Phase III Study of Neoadjuvant Lapatinib, Trastuzumab and Their Combination Plus Paclitaxel in Women With HER2/ErbB2 Positive Primary Breast Cancer

Study ID: NCT00553358

Study Description

Brief 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.

Detailed Description: This was a parallel group, three-arm, randomized, multicenter, open-label phase III study. The study compared the efficacy and tolerability of neoadjuvant lapatinib and paclitaxel, versus trastuzumab and paclitaxel, versus the combination of lapatinib with trastuzumab and paclitaxel given as neoadjuvant treatment in HER2/ErbB2 over-expressing and/or amplified primary breast cancer. Subjects were randomized to receive lapatinib, trastuzumab or lapatinib plus trastuzumab for a total of 6 weeks. After this biological window, subjects continued on the same targeted therapy plus weekly paclitaxel for a further 12 weeks, until definitive surgery (total neoadjuvant therapy duration of 18 weeks). Paclitaxel could be initiated at Week 4 if there is evidence of progressive disease (PD) at that time. Within 6 weeks after surgery, subjects received 3 cycles of adjuvant 5-flourouracil, epirubicin and cyclophosphamide (FEC) followed by the same targeted therapy as in the biological window of the neoadjuvant phase for a further 34 weeks (to complete 52 weeks of anti-HER2 therapy). After completing 52 weeks of (neo-)/adjuvant anti-HER2 therapy, subjects were scheduled to attend post-treatment follow-up every 3 months during the first year (months 12, 15, 18, 21, and 24), every 6months in Years 3 to 5 inclusive, and annually thereafter up to Year 10. Each subject was to be followed for 10 Years. All subjects were to be followed for EFS and OS up to 10 years from last subject randomized.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Novartis Investigative Site, Berazategui, Buenos Aires, Argentina

Novartis Investigative Site, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Novartis Investigative Site, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Novartis Investigative Site, Rosario, Santa Fe, Argentina

Novartis Investigative Site, Quilmes, , Argentina

Novartis Investigative Site, Santa Fe, , Argentina

Novartis Investigative Site, Tucuman, , Argentina

Novartis Investigative Site, Brussels, , Belgium

Novartis Investigative Site, Brussel, , Belgium

Novartis Investigative Site, Bruxelles, , Belgium

Novartis Investigative Site, Gent, , Belgium

Novartis Investigative Site, Leuven, , Belgium

Novartis Investigative Site, Namur, , Belgium

Novartis Investigative Site, Porto Alegre, Rio Grande Do Sul, Brazil

Novartis Investigative Site, Porto Alegre, Rio Grande Do Sul, Brazil

Novartis Investigative Site, Santo Andre, São Paulo, Brazil

Novartis Investigative Site, Sao Paulo, São Paulo, Brazil

Novartis Investigative Site, Montreal, Quebec, Canada

Novartis Investigative Site, Brno, , Czechia

Novartis Investigative Site, Novy Jicin, , Czechia

Novartis Investigative Site, Praha 10, , Czechia

Novartis Investigative Site, Bayonne, , France

Novartis Investigative Site, Bordeaux, , France

Novartis Investigative Site, Le Mans, , France

Novartis Investigative Site, Levallois-Perret, , France

Novartis Investigative Site, Paris, , France

Novartis Investigative Site, Reims, , France

Novartis Investigative Site, Strasbourg, , France

Novartis Investigative Site, Strasbourg, , France

Novartis Investigative Site, Toulouse, , France

Novartis Investigative Site, Villejuif Cedex, , France

Novartis Investigative Site, Freiburg, Baden-Wuerttemberg, Germany

Novartis Investigative Site, Karlsruhe, Baden-Wuerttemberg, Germany

Novartis Investigative Site, Fuerth, Bayern, Germany

Novartis Investigative Site, Nuernberg, Bayern, Germany

Novartis Investigative Site, Fuerstenwalde, Brandenburg, Germany

Novartis Investigative Site, Frankfurt am Main, Hessen, Germany

Novartis Investigative Site, Rostock, Mecklenburg-Vorpommern, Germany

Novartis Investigative Site, Stralsund, Mecklenburg-Vorpommern, Germany

Novartis Investigative Site, Celle, Niedersachsen, Germany

Novartis Investigative Site, Hannover, Niedersachsen, Germany

Novartis Investigative Site, Dortmund, Nordrhein-Westfalen, Germany

Novartis Investigative Site, Essen, Nordrhein-Westfalen, Germany

Novartis Investigative Site, Koeln, Nordrhein-Westfalen, Germany

Novartis Investigative Site, Witten, Nordrhein-Westfalen, Germany

Novartis Investigative Site, Halle, Sachsen-Anhalt, Germany

Novartis Investigative Site, Kiel, Schleswig-Holstein, Germany

Novartis Investigative Site, Berlin, , Germany

Novartis Investigative Site, Berlin, , Germany

Novartis Investigative Site, Hong Kong, , Hong Kong

Novartis Investigative Site, Kowloon, , Hong Kong

Novartis Investigative Site, Wanchai, , Hong Kong

Novartis Investigative Site, Budapest, , Hungary

Novartis Investigative Site, Bangalore, , India

Novartis Investigative Site, Hyderabad, , India

Novartis Investigative Site, Mumbai, , India

Novartis Investigative Site, Nagpur, , India

Novartis Investigative Site, New Delhi, , India

Novartis Investigative Site, New Delhi, , India

Novartis Investigative Site, Pune, , India

Novartis Investigative Site, Roma, Lazio, Italy

Novartis Investigative Site, Genova, Liguria, Italy

Novartis Investigative Site, Lecco, Lombardia, Italy

Novartis Investigative Site, Milano, Lombardia, Italy

Novartis Investigative Site, Milano, Lombardia, Italy

Novartis Investigative Site, Monza, Lombardia, Italy

Novartis Investigative Site, Sondrio, Lombardia, Italy

Novartis Investigative Site, Trento, Trentino-Alto Adige, Italy

Novartis Investigative Site, Seoul, , Korea, Republic of

Novartis Investigative Site, Seoul, , Korea, Republic of

Novartis Investigative Site, Seoul, , Korea, Republic of

Novartis Investigative Site, Seoul, , Korea, Republic of

Novartis Investigative Site, Songpa-gu, Seoul, , Korea, Republic of

Novartis Investigative Site, Vilnius, , Lithuania

Novartis Investigative Site, Oslo, , Norway

Novartis Investigative Site, Oslo, , Norway

Novartis Investigative Site, Karachi, , Pakistan

Novartis Investigative Site, Lima, , Peru

Novartis Investigative Site, Lima, , Peru

Novartis Investigative Site, Bucharest, , Romania

Novartis Investigative Site, Bucharest, , Romania

Novartis Investigative Site, Bucuresti, , Romania

Novartis Investigative Site, Cluj-Napoca, , Romania

Novartis Investigative Site, Moscow, , Russian Federation

Novartis Investigative Site, Ryazan, , Russian Federation

Novartis Investigative Site, St. Petersburg, , Russian Federation

Novartis Investigative Site, St. Petersburg, , Russian Federation

Novartis Investigative Site, Pretoria, Gauteng, South Africa

Novartis Investigative Site, Athlone Park, Amanzimtoti, , South Africa

Novartis Investigative Site, Capital Park, , South Africa

Novartis Investigative Site, Parktown, , South Africa

Novartis Investigative Site, Barcelona, , Spain

Novartis Investigative Site, Girona, , Spain

Novartis Investigative Site, Lerida, , Spain

Novartis Investigative Site, Madrid, , Spain

Novartis Investigative Site, Madrid, , Spain

Novartis Investigative Site, Mataro, , Spain

Novartis Investigative Site, Santiago de Compostela, , Spain

Novartis Investigative Site, Sevilla, , Spain

Novartis Investigative Site, Toledo, , Spain

Novartis Investigative Site, Torrevieja (Alicante), , Spain

Novartis Investigative Site, Valencia, , Spain

Novartis Investigative Site, Goteborg, , Sweden

Novartis Investigative Site, Changhua, , Taiwan

Novartis Investigative Site, Tainan, , Taiwan

Novartis Investigative Site, Taipei, , Taiwan

Novartis Investigative Site, Taipei, , Taiwan

Novartis Investigative Site, Taipei, , Taiwan

Novartis Investigative Site, Chernivtsi, , Ukraine

Novartis Investigative Site, Dnipropetrovsk, , Ukraine

Novartis Investigative Site, Kharkiv, , Ukraine

Novartis Investigative Site, Kiev, , Ukraine

Novartis Investigative Site, Krivoy Rog, , Ukraine

Novartis Investigative Site, Kyiv, , Ukraine

Novartis Investigative Site, Lviv, , Ukraine

Novartis Investigative Site, Odessa, , Ukraine

Novartis Investigative Site, Simferopol, , Ukraine

Novartis Investigative Site, Epping, Essex, United Kingdom

Novartis Investigative Site, Bournemouth, , United Kingdom

Novartis Investigative Site, London, , United Kingdom

Novartis Investigative Site, London, , United Kingdom

Novartis Investigative Site, Nottingham, , United Kingdom

Contact Details

Name: Novartis Pharmaceuticals

Affiliation: Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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