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Completed

NCT Number: NCT01271920

Combination of AUY922 With Trastuzumab in HER2+ Advanced Breast Cancer Patients Previously Treated With Trastuzumab

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unacceptable toxicity, death, or discontinuation from the study for any other reason, such as patient refusal, withdrawn consent, lost to follow-up or investigator decision.

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Key information

Conditions

Advanced HER2-positive Breast Cancer Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Novartis Investigative Site, Dijon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AUY922

Drug

Trastuzumab

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jan 7, 2011
Registry last updated
Dec 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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