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

NCT00553358 | Completed Phase 3 Results DMC

• 3 other identifiers: EGF1069032006-000564-81CLAP016B2302
• Study Type: interventional
• Target: 455
• Locations: 24 countries
• Sites: 121

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.

Conditions

Neoplasms, Breast

Keywords

Lapatinib; ErbB2+; Early Breast Cancer; Neoadjuvant; breast carcinoma; breast cancer; breast lump; HER2 positive metastatic breast cancer; breast cancer positive for human epidermal growth factor receptor 2 (HER2) HER2 positive metastatic breast cancer; breast cancer progression; estrogen-receptor (ER) positive(+) breast cancer; Paget's disease

Outcome Measures

Primary Outcomes (1)

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

  Pathological complete response is defined as no invasive cancer in the breast or only non-invasive in situ cancer in the breast specimen. Surgical breast and axillary node resection specimens were evaluated for pathologic tumor response according to National Surgical Adjuvant Breast and Bowel Project (NSABP) guidelines, which do not take into account the histological nodal status.

  Weeks 20 to 22

Secondary Outcomes (20)

• Number of Participants With Overall Response at Week 6

  Week 6

• Overall Response at the Time of Surgery

  Time of surgery (Weeks 20 to 22)

• Number of Participants With Negative Lymph Nodes at the Time of Surgery

  Time of surgery (Weeks 20 to 22)

• Number of Participants With Actual Indicated Surgery

  At surgery (Weeks 20 to 22)

• Mean Change From Baseline in Tumor Size at Week 6 and at Surgery

  Week 6 and surgery (Weeks 20 to 22)

Study Arms (3)

Arm 1 Lapatinib

EXPERIMENTAL

1500 mg lapatinib for 6 weeks followed by lapatinib plus weekly paclitaxel for an additional 12 weeks. After definitive surgery, 3 cycles of adjuvant FEC followed by 34 weeks of adjuvant lapatinib.

Drug: Lapatinib; Drug: Paclitaxel

Arm 2 Trastuzumab

ACTIVE COMPARATOR

4 mg/kg IV loading dose followed by 2 mg/kg IV weekly trastuzumab for 6 weeks followed by 2 mg/kg trastuzumab plus weekly paclitaxel for an additional 12 weeks. After definitive surgery, 3 cycles of adjuvant FEC followed by 34 weeks of adjuvant trastuzumab (8 mg/kg loading dose followed by 6 mg/kg every 3 weeks).

Biological: Trastuzumab; Drug: Paclitaxel

Arm 3 Lapatinib plus Trastuzumab

EXPERIMENTAL

1000 mg lapatinib plus 4 mg/kg IV loading dose followed by 2 mg/kg IV weekly trastuzumab for 6 weeks, followed by 750 mg lapatinib plus 2 mg/kg IV weekly trastuzumab plus weekly paclitaxel for an additional 12 weeks. After definitive surgery, 3 cycles of adjuvant FEC followed by 34 weeks of adjuvant lapatinib (1000 mg) in combination with trastuzumab (8 mg/kg loading dose followed by 6 mg/kg every 3 weeks).

Drug: Lapatinib; Biological: Trastuzumab; Drug: Paclitaxel

Interventions

Lapatinib DRUG

Small molecule receptor tyrosine kinase inhibitor

Arm 1 Lapatinib; Arm 3 Lapatinib plus Trastuzumab

Trastuzumab BIOLOGICAL

Therapeutic Monoclonal Antibody

Arm 2 Trastuzumab; Arm 3 Lapatinib plus Trastuzumab

Paclitaxel DRUG

antimicrotubule agent

Arm 1 Lapatinib; Arm 2 Trastuzumab; Arm 3 Lapatinib plus Trastuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• Received any prior treatment for primary invasive breast cancer;
• Previous (less than 10 years) or current history of malignant neoplasms, except for curatively treated:
• Basal and squamous cell carcinoma of the skin;
• Carcinoma in situ of the cervix.
• Patients with a prior malignancy diagnosed more than 10 years prior to randomisation may enter the study. Patients must have been curatively treated with surgery alone. Radiation therapy or systemic therapy (chemotherapy or endocrine) are NOT permitted. Prior diagnoses of breast cancer or melanoma are excluded.
• Diagnosis of inflammatory breast cancer;
• Bilateral cancer;
• This criterion has been deleted from the protocol Version 1. Patients with multi-focal cancer are no longer excluded.
• Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension (≥180/110), unstable diabetes mellitus, dyspnoea at rest, or chronic therapy with oxygen;
• Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety;
• Unresolved or unstable, serious adverse events from prior administration of another investigational drug;
• Active or uncontrolled infection;
• Dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of ICF;
• Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded;
• Concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy other than the trial therapies);

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead
• Breast International Group: collaborator
• SOLTI Breast Cancer Research Group: collaborator

Study Sites (121)

Novartis Investigative Site

Berazategui, Buenos Aires, B1880BBF, Argentina

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Novartis Investigative Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1125ABD, Argentina

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Ciudad Autonoma de Buenos Aires, Buenos Aires, C1185AAT, Argentina

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Rosario, Santa Fe Province, S2000KZE, Argentina

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Quilmes, 1878, Argentina

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San Miguel de Tucumán, 4000, Argentina

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Santa Fe, 3000, Argentina

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Brussels, 1000, Belgium

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Brussels, 1070, Belgium

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Brussels, 1090, Belgium

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Ghent, 9000, Belgium

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Leuven, 3000, Belgium

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Namur, 5000, Belgium

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Porto Alegre, Rio Grande do Sul, 90430-090, Brazil

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Porto Alegre, Rio Grande do Sul, 90560-030, Brazil

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Santo André, São Paulo, 09060-650, Brazil

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São Paulo, São Paulo, 03102-002, Brazil

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Montreal, Quebec, H4J 1C5, Canada

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Brno, 656 53, Czechia

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Nový Jičín, 741 01, Czechia

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Prague, 100 34, Czechia

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Bayonne, 64100, France

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Bordeaux, 33077, France

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Le Mans, 72015, France

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Levallois-Perret, 92300, France

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Paris, 75010, France

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Reims, 51100, France

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Strasbourg, 67000, France

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Strasbourg, 67085, France

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Toulouse, 31076, France

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Villejuif, 94805, France

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Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

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Karlsruhe, Baden-Wurttemberg, 76135, Germany

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Fürth, Bavaria, 90766, Germany

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Nuremberg, Bavaria, 90340, Germany

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Fürstenwalde, Brandenburg, 15517, Germany

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Frankfurt am Main, Hesse, 60590, Germany

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Celle, Lower Saxony, 29223, Germany

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Hanover, Lower Saxony, 30625, Germany

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Rostock, Mecklenburg-Vorpommern, 18059, Germany

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Stralsund, Mecklenburg-Vorpommern, 18435, Germany

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Cologne, North Rhine-Westphalia, 50937, Germany

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Dortmund, North Rhine-Westphalia, 44137, Germany

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Essen, North Rhine-Westphalia, 45122, Germany

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Witten, North Rhine-Westphalia, 58452, Germany

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Halle, Saxony-Anhalt, 06120, Germany

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Kiel, Schleswig-Holstein, 24105, Germany

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Berlin, 13125, Germany

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Berlin, 13589, Germany

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Hong Kong, Hong Kong

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Kowloon, Hong Kong

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Wan Chai, Hong Kong

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Budapest, H-1122, Hungary

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Bangalore, 560029, India

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Hyderabad, 500082, India

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Mumbai, 400012, India

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Nagpur, 440010, India

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New Delhi, 110060, India

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New Delhi, 110076, India

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Pune, 411001, India

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Rome, Lazio, 00144, Italy

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Genoa, Liguria, 16132, Italy

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Lecco, Lombardy, 23900, Italy

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Milan, Lombardy, 20132, Italy

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Milan, Lombardy, 20141, Italy

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Monza, Lombardy, 20052, Italy

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Sondrio, Lombardy, 23100, Italy

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Trento, Trentino-Alto Adige, 38100, Italy

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Vilnius, LT-08660, Lithuania

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Oslo, 0310, Norway

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Oslo, 0407, Norway

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Karachi, 74800, Pakistan

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Lima, Lima 11, Peru

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Lima, Lima 34, Peru

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Bucharest, 022328, Romania

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Bucharest, 050098, Romania

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Cluj-Napoca, 400015, Romania

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Moscow, 115 478, Russia

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Ryazan, 390011, Russia

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Saint Petersburg, 197022, Russia

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Saint Petersburg, 197758, Russia

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Pretoria, Gauteng, 0181, South Africa

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Athlone Park, Amanzimtoti, 4126, South Africa

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Capital Park, 0002, South Africa

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Parktown, 2193, South Africa

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Seoul, 003722, South Korea

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Seoul, 06351, South Korea

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Seoul, 135-710, South Korea

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Seoul, 138-736, South Korea

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Songpa-gu, Seoul, 138-736, South Korea

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Barcelona, 08035, Spain

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Girona, 17007, Spain

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Lleida, 25198, Spain

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Madrid, 28033, Spain

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Madrid, 28041, Spain

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Mataró, 08304, Spain

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Santiago de Compostela, 15706, Spain

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Seville, 41013, Spain

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Toledo, 45004, Spain

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Torrevieja (Alicante), 03186, Spain

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Valencia, 46014, Spain

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Gothenburg, SE-413 45, Sweden

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Changhua, 500, Taiwan

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Tainan, 704, Taiwan

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Taipei, 100, Taiwan

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Taipei, 104, Taiwan

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Taipei, 112, Taiwan

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Chernivtsi, 58013, Ukraine

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Dnipropetrovsk, 49100, Ukraine

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Kharkiv, 61070, Ukraine

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Kiev, 03115, Ukraine

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Kryvyi Rih, 50048, Ukraine

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Kyiv, 03022, Ukraine

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Lviv, 79031, Ukraine

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Odesa, 65055, Ukraine

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Simferopol, 95023, Ukraine

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Epping, Essex, CM16 6TN, United Kingdom

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Bournemouth, BH7 7DW, United Kingdom

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London, EC1A 7BE, United Kingdom

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London, SE1 9RT, United Kingdom

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Nottingham, NG5 1PB, United Kingdom

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Related Publications (11)

• Baselga J, Piccart M, Gelber R, di CosimoS, Viale G, Koehler M, Rojo F. Neo-ALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) study [BIG 1-06 /solti/EGF106903]: a phase III translational study for HER2-overexpressing early breast cancer. [Lancet]. 2012;S140-6736(11):

  BACKGROUND

• Rediti M, Venet D, Joaquin Garcia A, Maetens M, Vincent D, Majjaj S, El-Abed S, Di Cosimo S, Ueno T, Izquierdo M, Piccart M, Pusztai L, Loi S, Salgado R, Viale G, Rothe F, Sotiriou C. Identification of HER2-positive breast cancer molecular subtypes with potential clinical implications in the ALTTO clinical trial. Nat Commun. 2024 Nov 29;15(1):10402. doi: 10.1038/s41467-024-54621-3.

  PMID: 39613746 DERIVED

• Chumsri S, Li Z, Serie DJ, Norton N, Mashadi-Hossein A, Tenner K, Brauer HA, Warren S, Danaher P, Colon-Otero G, Partridge AH, Carey LA, Hilbers F, Van Dooren V, Holmes E, Di Cosimo S, Werner O, Huober JB, Dueck AC, Sotiriou C, Saura C, Moreno-Aspitia A, Knutson KL, Perez EA, Thompson EA. Adaptive immune signature in HER2-positive breast cancer in NCCTG (Alliance) N9831 and NeoALTTO trials. NPJ Breast Cancer. 2022 May 24;8(1):68. doi: 10.1038/s41523-022-00430-0.

  PMID: 35610260 DERIVED

• Pizzamiglio S, Cosentino G, Ciniselli CM, De Cecco L, Cataldo A, Plantamura I, Triulzi T, El-Abed S, Wang Y, Bajji M, Nuciforo P, Huober J, Ellard SL, Rimm DL, Gombos A, Daidone MG, Verderio P, Tagliabue E, Di Cosimo S, Iorio MV. What if the future of HER2-positive breast cancer patients was written in miRNAs? An exploratory analysis from NeoALTTO study. Cancer Med. 2022 Jan;11(2):332-339. doi: 10.1002/cam4.4449. Epub 2021 Dec 17.

  PMID: 34921525 DERIVED

• Powles RL, Redmond D, Sotiriou C, Loi S, Fumagalli D, Nuciforo P, Harbeck N, de Azambuja E, Sarp S, Di Cosimo S, Huober J, Baselga J, Piccart-Gebhart M, Elemento O, Pusztai L, Hatzis C. Association of T-Cell Receptor Repertoire Use With Response to Combined Trastuzumab-Lapatinib Treatment of HER2-Positive Breast Cancer: Secondary Analysis of the NeoALTTO Randomized Clinical Trial. JAMA Oncol. 2018 Nov 1;4(11):e181564. doi: 10.1001/jamaoncol.2018.1564. Epub 2018 Nov 8.

  PMID: 29902299 DERIVED

• Fumagalli D, Venet D, Ignatiadis M, Azim HA Jr, Maetens M, Rothe F, Salgado R, Bradbury I, Pusztai L, Harbeck N, Gomez H, Chang TW, Coccia-Portugal MA, Di Cosimo S, de Azambuja E, de la Pena L, Nuciforo P, Brase JC, Huober J, Baselga J, Piccart M, Loi S, Sotiriou C. RNA Sequencing to Predict Response to Neoadjuvant Anti-HER2 Therapy: A Secondary Analysis of the NeoALTTO Randomized Clinical Trial. JAMA Oncol. 2017 Feb 1;3(2):227-234. doi: 10.1001/jamaoncol.2016.3824.

  PMID: 27684533 DERIVED

• Salgado R, Denkert C, Campbell C, Savas P, Nuciforo P, Aura C, de Azambuja E, Eidtmann H, Ellis CE, Baselga J, Piccart-Gebhart MJ, Michiels S, Bradbury I, Sotiriou C, Loi S. Tumor-Infiltrating Lymphocytes and Associations With Pathological Complete Response and Event-Free Survival in HER2-Positive Early-Stage Breast Cancer Treated With Lapatinib and Trastuzumab: A Secondary Analysis of the NeoALTTO Trial. JAMA Oncol. 2015 Jul;1(4):448-54. doi: 10.1001/jamaoncol.2015.0830.

  PMID: 26181252 DERIVED

• Nuciforo PG, Aura C, Holmes E, Prudkin L, Jimenez J, Martinez P, Ameels H, de la Pena L, Ellis C, Eidtmann H, Piccart-Gebhart MJ, Scaltriti M, Baselga J. Benefit to neoadjuvant anti-human epidermal growth factor receptor 2 (HER2)-targeted therapies in HER2-positive primary breast cancer is independent of phosphatase and tensin homolog deleted from chromosome 10 (PTEN) status. Ann Oncol. 2015 Jul;26(7):1494-500. doi: 10.1093/annonc/mdv175. Epub 2015 Apr 7.

  PMID: 25851628 DERIVED

• de Azambuja E, Holmes AP, Piccart-Gebhart M, Holmes E, Di Cosimo S, Swaby RF, Untch M, Jackisch C, Lang I, Smith I, Boyle F, Xu B, Barrios CH, Perez EA, Azim HA Jr, Kim SB, Kuemmel S, Huang CS, Vuylsteke P, Hsieh RK, Gorbunova V, Eniu A, Dreosti L, Tavartkiladze N, Gelber RD, Eidtmann H, Baselga J. Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): survival outcomes of a randomised, open-label, multicentre, phase 3 trial and their association with pathological complete response. Lancet Oncol. 2014 Sep;15(10):1137-46. doi: 10.1016/S1470-2045(14)70320-1. Epub 2014 Aug 14.

  PMID: 25130998 DERIVED

• Yarden Y, Pines G. The ERBB network: at last, cancer therapy meets systems biology. Nat Rev Cancer. 2012 Jul 12;12(8):553-63. doi: 10.1038/nrc3309.

  PMID: 22785351 DERIVED

• Baselga J, Bradbury I, Eidtmann H, Di Cosimo S, de Azambuja E, Aura C, Gomez H, Dinh P, Fauria K, Van Dooren V, Aktan G, Goldhirsch A, Chang TW, Horvath Z, Coccia-Portugal M, Domont J, Tseng LM, Kunz G, Sohn JH, Semiglazov V, Lerzo G, Palacova M, Probachai V, Pusztai L, Untch M, Gelber RD, Piccart-Gebhart M; NeoALTTO Study Team. Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2012 Feb 18;379(9816):633-40. doi: 10.1016/S0140-6736(11)61847-3. Epub 2012 Jan 17.

  PMID: 22257673 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Osteitis Deformans

Interventions

Lapatinib; Trastuzumab; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Clinical Disclosure Office
• Organization: Novartis Pharmaceuticals

Novartis.email@Novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2007
• First Posted: November 5, 2007
• Study Start: January 5, 2008
• Primary Completion: May 27, 2010
• Study Completion: December 23, 2019
• Last Updated: September 21, 2021
• Results First Posted: October 13, 2011

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share

Locations

GB (5); IN (7); ZA (4); UA (9); PE (2); SE (1); AR (7); IT (8); HU (1); FR (10); CZ (3); BR (4); DE (18); NO (2); RO (3); RU (4); LI (1); PA (1); KR (5); ES (11); HK (3); BE (6); CA (1); TW (5)