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Trial record 1 of 1 for:    NCT01271920
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Combination of AUY922 With Trastuzumab in HER2+ Advanced Breast Cancer Patients Previously Treated With Trastuzumab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01271920
Recruitment Status : Completed
First Posted : January 7, 2011
Last Update Posted : December 8, 2020
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:

The phase Ib part of the trial will assess the MTD of AUY922 in combination with Trastuzumab in patients with Trastuzumab-refractory locally advanced or metastatic HER2+. The MTD is defined as the highest drug dosage not causing in the first cycle of treatment (28 days) medically unacceptable dose limiting toxicity (DLT).

The phase II part of the trial will assess any potential effect on efficacy of adding AUY922 to Trastuzumab in patients with Trastuzumab-refractory locally advanced or metastatic HER2+ breast cancer.

Both AUY922 and Trastuzumab will be administered as a weekly IV infusion. Treatment should be continued as long as the patient does not have disease progression and tolerates the treatment. The following reasons are examples of acceptable reasons for discontinuing the study; tumor progression (by RECIST, as assessed by the investigator), unacceptable toxicity, death, or discontinuation from the study for any other reason, such as patient refusal, withdrawn consent, lost to follow-up or investigator decision.

Condition or disease Intervention/treatment Phase
Advanced HER2-positive Breast Cancer Drug: AUY922 Drug: Trastuzumab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib/II, Multi-center, Open-label Study to Evaluate the Efficacy of AUY922 in Combination With Trastuzumab in Patients With Locally Advanced or Metastatic HER2-positive Breast Cancer, That Has Progressed After or During at Least One Trastuzumab-containing Regimen
Study Start Date : September 2010
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

Arm Intervention/treatment
Experimental: AUY922 + Trastuzumab Drug: AUY922
Drug: Trastuzumab

Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) and/or recommended phase two dose (RPTD) of AUY922 in combination with Trastuzumab (phase lb) [ Time Frame: 4 weeks ]
  2. Overall Response Rate as assessed by RECIST (phase ll) [ Time Frame: Every 8 weeks for the first 24 weeks and every 12 weeks thereafter ]

Secondary Outcome Measures :
  1. Assess concentration of AUY922 and BJP762 in the blood at different time points (phase lb & ll) [ Time Frame: 4 weeks ]
  2. Assess frequency, intensity and duration of Adverse Events as a Measure of Safety and Tolerability (phase lb & ll) [ Time Frame: average 6 months ]
  3. Progression Free Survival (PFS) at the RPTD dose (phase ll only) [ Time Frame: every 3 months until 24 months after the last patient has been enrolled ]
  4. Overall Survival (OS) at the RPTD dose [ Time Frame: every 3 months until 24 months after the last patient has been enrolled ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Female patients with confirmed HER-2 positive , non-operable locally advanced or metastatic breast cancer
  • All patients must have received at least 1 but no more than 2 prior anti HER2 based regimens including at least 1 regimen containing Trastuzumab.
  • All patients must have at least one measurable lesion as defined by RECIST criteria.
  • All patients must have documented progressive disease following the last line of therapy before entering the study
  • ECOG Performance status ≤ 1

Exclusion Criteria:

  • Patients with known CNS metastasis which are: symptomatic or require treatment for symptom control and/or growing
  • Prior treatment with any HSP90 or HDAC inhibitor
  • Impaired cardiac function
  • Acute or chronic liver or renal disease
  • Patients who are currently receiving treatment with any medication which has a relative risk of prolonging the QTc interval or inducing Torsades de Pointes and cannot be switched or discontinued to an alternative drug prior to commencing AUY922
  • Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention
  • Patients who do not have either an archival tumor sample available or are unwilling to have a fresh tumor sample collected at baseline.

Other protocol-defined inclusion/exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01271920

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United States, Arkansas
Highlands Oncology Group Dept of Highlands Oncology Grp
Fayetteville, Arkansas, United States, 72703
Novartis Investigative Site
Dijon Cedex, France, 21034
Novartis Investigative Site
Saint-Herblain Cédex, France, 44805
Novartis Investigative Site
Essen, Germany, 45147
Novartis Investigative Site
Tuebingen, Germany, 72076
Novartis Investigative Site
Prato, PO, Italy, 59100
Novartis Investigative Site
Candiolo, TO, Italy, 10060
Novartis Investigative Site
Singapore, Singapore, 119228
Novartis Investigative Site
Malaga, Andalucia, Spain, 29010
Novartis Investigative Site
Santiago de Compostela, Galicia, Spain, 15706
Novartis Investigative Site
Madrid, Spain, 28009
Novartis Investigative Site
Stockholm, Sweden, SE-171 76
United Kingdom
Novartis Investigative Site
Birmingham, United Kingdom, B15 2TT
Novartis Investigative Site
Leicester, United Kingdom, LE1 5WW
Novartis Investigative Site
Manchester, United Kingdom, M20 2BX
Novartis Investigative Site
Oxford, United Kingdom, OX2 6HE
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Investigative Site Novartis Investigative Site
Additional Information:
Publications of Results:
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT01271920    
Other Study ID Numbers: CAUY922A2109
2009-015628-27 ( EudraCT Number )
First Posted: January 7, 2011    Key Record Dates
Last Update Posted: December 8, 2020
Last Verified: February 2017
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
advanced HER2-positive breast cancer,
2nd or 3rd line treatment
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents