A Trial of Panobinostat and Trastuzumab for Adult Female Patients With HER2 Positive Metastatic Breast Cancer (MBC) Whose Disease Has Progressed on or After Trastuzumab

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition:	Breast Cancer
Interventions:	Drug: Panobinostat; Drug: Trastuzumab

  Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Eligible participants were allocated to dose escalation arm 1 (i.v. panobinostat) or arm 2 (oral panobinostat) according to a pre-determined sequence in the ratio 1:1. Each cohort consisted of newly enrolled participants. This study included a dose escalation phase to establish the maximum tolerated dose (MTD) and a dose expansion phase.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Escalation: i.v. Arm - 10mg/m^2	10 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
Escalation: i.v. Arm - 15mg/m^2	15 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
Escalation/Expansion: i.v. Arm -20mg/m^2	20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
Oral Arm - Schedule A 20mg	20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
Oral Arm - Schedule B 15 mg	15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
Oral Arm - Schedule B 20mg	20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.

Participant Flow:   Overall Study

	Escalation: i.v. Arm - 10mg/m^2	Escalation: i.v. Arm - 15mg/m^2	Escalation/Expansion: i.v. Arm -20mg/m^2	Oral Arm - Schedule A 20mg	Oral Arm - Schedule B 15 mg	Oral Arm - Schedule B 20mg
STARTED	7	7	21 [1]	6	12	3
Maximum Tolerated Dose Determining Set	5	7	18 [2]	6	12	3
COMPLETED	0	0	0	0	0	0
NOT COMPLETED	7	7	21	6	12	3
Adverse Event	2	0	1	0	1	0
Abnormal test procedure(s)	0	0	1	0	0	0
Withdrawal by Subject	0	0	3	1	0	0
New cancer therapy	0	0	1	0	0	0
Disease progression	5	7	15	5	11	3

[1]	7 participants belonged to the dose expansion group at 20mg/m2 i.v.
[2]	6 participants belonged to the dose expansion group at 20mg/m2 i.v.

  Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Escalation: i.v. Arm - 10mg/m^2	10 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
Escalation: i.v. Arm - 15mg/m^2	15 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
Escalation/Expansion: i.v. Arm -20mg/m^2	20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
Oral Arm - Schedule A 20mg	20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
Oral Arm - Schedule B 15mg	15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
Oral Arm - Schedule B 20mg	20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
Total	Total of all reporting groups

Baseline Measures

	Escalation: i.v. Arm - 10mg/m^2	Escalation: i.v. Arm - 15mg/m^2	Escalation/Expansion: i.v. Arm -20mg/m^2	Oral Arm - Schedule A 20mg	Oral Arm - Schedule B 15mg	Oral Arm - Schedule B 20mg	Total
Overall Participants Analyzed; [Units: Participants]	7	7	21	6	12	3	56
Age; [Units: Years]; Median (Full Range)	58.0; (35.0 to 60.0)	49.0; (33.0 to 60.0)	57.0; (37.0 to 83.0)	54.5; (49.0 to 59.0)	53.5; (40.0 to 65.0)	47.0; (38.0 to 60.0)	53.0; (33.0 to 83.0)
Gender, Customized; [Units: Participants]
Female	7	7	21	6	12	3	56

  Outcome Measures

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1. Primary:

Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: day 21 ]

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2. Secondary:

Number of Participants With Best Overall Response [ Time Frame: day 21 ]

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  Serious Adverse Events

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  Other Adverse Events

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  Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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Certain Agreements:  

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is: The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo. The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.; Restriction Description: The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.

Results Point of Contact:  

Name/Title: Study Director
Organization: Novartis
phone: 862-778-8300

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT00567879 History of Changes
Other Study ID Numbers:	CLBH589C2204; 2007-002449-19 ( EudraCT Number )
First Submitted:	December 4, 2007
First Posted:	December 5, 2007
Results First Submitted:	April 4, 2016
Results First Posted:	May 9, 2016
Last Update Posted:	May 9, 2016