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First Line Therapy for Patients With Metastatic Breast Cancer

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00456846
First received: April 3, 2007
Last updated: April 27, 2016
Last verified: April 2016
Results First Received: June 19, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Metastatic Breast Cancer
Intervention: Drug: ABI-007

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Abraxane (Prior Taxane Therapy) Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest. Therapy continued until disease progression or unacceptable toxicity.
Abraxane (No Prior Taxane Therapy) Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest. Therapy continued until disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Abraxane (Prior Taxane Therapy)   Abraxane (No Prior Taxane Therapy)
STARTED   47   76 
COMPLETED   31 [1]   48 [1] 
NOT COMPLETED   16   28 
Adverse Event                2                15 
Physician Decision                11                6 
Protocol Deviation                2                0 
Participant Discretion                1                5 
Unspecified                0                2 
[1] Treatment considered completed upon disease progression



  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.
Treated Population

Reporting Groups
  Description
Abraxane (Prior Taxane Therapy) Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
Abraxane (No Prior Taxane Therapy) Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
Total Total of all reporting groups

Baseline Measures
   Abraxane (Prior Taxane Therapy)   Abraxane (No Prior Taxane Therapy)   Total 
Overall Participants Analyzed 
[Units: Participants]
 47   76   123 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.3  (9.78)   58.3  (10.88)   57.2  (10.54) 
Gender 
[Units: Participants]
     
Female   47   76   123 
Male   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
     
Asian   0   5   5 
Black, of African Heritage   2   3   5 
Native Hawaiian or Other Pacific Islander   1   0   1 
White, Non-Hispanic/Non Latino   41   60   101 
White, Hispanic or Latino   0   5   5 
Other-Unspecified   3   3   6 
Menopausal Status 
[Units: Participants]
     
Premenopausal   12   12   24 
Postmenopausal   35   64   99 
Stage at Primary Diagnosis [1] 
[Units: Participants]
     
Stage I   4   12   16 
Stage IIa   7   12   19 
Stage IIb   14   13   27 
Stage IIIa   11   8   19 
Stage IIIb   6   4   10 
Stage IIIc   5   5   10 
Stage IV   0   19   19 
Unknown   0   3   3 
[1]

Invasive breast cancer stages:

Stage I-cancer cells are breaking through to or invading normal surrounding breast tissue.

Stage IIa-breast tumor about 2cm and involvement of ancillary lymph nodes. Stage IIb-a larger tumor than earlier phases. Stage IIIa-axillary lymph nodes clumping together. Stage IIIb-spread further to the skin, breast bone or chest wall. Stage IIIc-expanded involvement of lymph nodes. Stage IV-cancer that has spread beyond the breast and nearby lymph nodes to other organs of the body.

Eastern Cooperative Oncology Group (ECOG) Performance Status [1] 
[Units: Participants]
     
0 (fully active)   21   38   59 
1 (restrictive but ambulatory)   22   30   52 
2 (ambulatory but unable to work)   4   8   12 
3 (limited self-care) + 4 (completely disabled)   0   0   0 
[1] Eastern Cooperative Oncology Group (ECOG) Performance Status is used to assess the progress of disease in a patient, how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis.
Physician Assessment of Peripheral Neuropathy] [2] [1] 
[Units: Participants]
     
Grade 0   37   69   106 
Grade 1   10   7   17 
[1] The physician assessed sensory neuropathy using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) of "Neurology -- Neuropathy - Sensory". The scale is 0 = normal, 1 = asymptomatic; loss of deep tendon reflexes or paresthesia (including tingling) but not interfering with function, 2 = sensory alteration or paresthesia (including tingling), interfering with activities of daily living (ADL); 3 = Sensory alteration or parasthesia interfering with ADLs; 4 = disabling


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Objective Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 Based on Investigator and Independent Reviewers   [ Time Frame: Every 8 weeks from study start until disease progression; Up to 61 months ]

2.  Secondary:   Percentage of Participants With Disease Control   [ Time Frame: Every 8 weeks from study start until disease progression; Up to 61 months ]

3.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: Study start until disease progression, death, or up to data cut off of 31 May 2013; up to 61 months ]

4.  Secondary:   Duration of Response Based on Independent Reviewer Assessment   [ Time Frame: Initial response until disease progression; or until data cut off 31 May 2013; up to 61 months ]

5.  Secondary:   Duration of Response Based on Investigator Assessment   [ Time Frame: Initial response until disease progression; or until data cut off 31 May 2013; up to 61 months ]

6.  Secondary:   Patient Survival   [ Time Frame: Study start until death, or until data cut-off 31 May 2013; up to 61 months ]

7.  Secondary:   Number of Participants Experiencing Dose Reductions, Interruptions, or Dose Delays of Study Drug   [ Time Frame: Day 1 of study drug to Day 940; data cut off 31 May 2013 ]

8.  Secondary:   Number of Participants With Treatment-Emergent Adverse Events   [ Time Frame: Day 1 to Day 940 ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame Any Adverse Event (AE) that started after initial study drug administration through the end of the study or 30 days after the last treatment, whichever was later, were followed until the AE had resolved or stabilized. Upt to 61 months.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5.0  

Reporting Groups
  Description
Abraxane (Prior Taxane Therapy) Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
Abraxane (No Prior Taxane Therapy) Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest

Other Adverse Events
    Abraxane (Prior Taxane Therapy)   Abraxane (No Prior Taxane Therapy)
Total, other (not including serious) adverse events     
# participants affected / at risk   46/47 (97.87%)   75/76 (98.68%) 
Blood and lymphatic system disorders     
Anaemia † 1     
# participants affected / at risk   3/47 (6.38%)   4/76 (5.26%) 
Neutropenia † 1     
# participants affected / at risk   7/47 (14.89%)   13/76 (17.11%) 
Thrombocytopenia † 1     
# participants affected / at risk   3/47 (6.38%)   2/76 (2.63%) 
Eye disorders     
Dry eye † 1     
# participants affected / at risk   1/47 (2.13%)   5/76 (6.58%) 
Lacrimation increased † 1     
# participants affected / at risk   5/47 (10.64%)   14/76 (18.42%) 
Vision blurred † 1     
# participants affected / at risk   5/47 (10.64%)   5/76 (6.58%) 
Gastrointestinal disorders     
Abdominal pain † 1     
# participants affected / at risk   3/47 (6.38%)   12/76 (15.79%) 
Abdominal pain upper † 1     
# participants affected / at risk   1/47 (2.13%)   4/76 (5.26%) 
Constipation † 1     
# participants affected / at risk   15/47 (31.91%)   15/76 (19.74%) 
Diarrhoea † 1     
# participants affected / at risk   15/47 (31.91%)   37/76 (48.68%) 
Dry mouth † 1     
# participants affected / at risk   3/47 (6.38%)   3/76 (3.95%) 
Dyspepsia † 1     
# participants affected / at risk   11/47 (23.40%)   9/76 (11.84%) 
Dysphagia † 1     
# participants affected / at risk   4/47 (8.51%)   2/76 (2.63%) 
Gastrooesophageal reflux disease † 1     
# participants affected / at risk   3/47 (6.38%)   2/76 (2.63%) 
Haemorrhoids † 1     
# participants affected / at risk   1/47 (2.13%)   4/76 (5.26%) 
Nausea † 1     
# participants affected / at risk   24/47 (51.06%)   47/76 (61.84%) 
Stomatitis † 1     
# participants affected / at risk   6/47 (12.77%)   18/76 (23.68%) 
Vomiting † 1     
# participants affected / at risk   13/47 (27.66%)   22/76 (28.95%) 
General disorders     
Asthenia † 1     
# participants affected / at risk   5/47 (10.64%)   6/76 (7.89%) 
Chills † 1     
# participants affected / at risk   6/47 (12.77%)   5/76 (6.58%) 
Fatigue † 1     
# participants affected / at risk   33/47 (70.21%)   55/76 (72.37%) 
Influenza like illness † 1     
# participants affected / at risk   1/47 (2.13%)   5/76 (6.58%) 
Mucosal inflammation † 1     
# participants affected / at risk   1/47 (2.13%)   4/76 (5.26%) 
Non-cardiac chest pain † 1     
# participants affected / at risk   3/47 (6.38%)   4/76 (5.26%) 
Oedema † 1     
# participants affected / at risk   2/47 (4.26%)   4/76 (5.26%) 
Oedema peripheral † 1     
# participants affected / at risk   13/47 (27.66%)   22/76 (28.95%) 
Pain † 1     
# participants affected / at risk   4/47 (8.51%)   3/76 (3.95%) 
Performance status decreased † 1     
# participants affected / at risk   2/47 (4.26%)   6/76 (7.89%) 
Pyrexia † 1     
# participants affected / at risk   8/47 (17.02%)   17/76 (22.37%) 
Infections and infestations     
Cellulitis † 1     
# participants affected / at risk   3/47 (6.38%)   0/76 (0.00%) 
Influenza † 1     
# participants affected / at risk   2/47 (4.26%)   4/76 (5.26%) 
Nasopharyngitis † 1     
# participants affected / at risk   4/47 (8.51%)   6/76 (7.89%) 
Sinusitis † 1     
# participants affected / at risk   4/47 (8.51%)   4/76 (5.26%) 
Upper respiratory tract infection † 1     
# participants affected / at risk   6/47 (12.77%)   6/76 (7.89%) 
Urinary tract infection † 1     
# participants affected / at risk   6/47 (12.77%)   8/76 (10.53%) 
Injury, poisoning and procedural complications     
Fall † 1     
# participants affected / at risk   3/47 (6.38%)   1/76 (1.32%) 
Investigations     
Aspartate aminotransferase increased † 1     
# participants affected / at risk   0/47 (0.00%)   5/76 (6.58%) 
Haemoglobin decreased † 1     
# participants affected / at risk   4/47 (8.51%)   9/76 (11.84%) 
Neutrophil count decreased † 1     
# participants affected / at risk   0/47 (0.00%)   4/76 (5.26%) 
Weight decreased † 1     
# participants affected / at risk   6/47 (12.77%)   6/76 (7.89%) 
Weight increased † 1     
# participants affected / at risk   6/47 (12.77%)   7/76 (9.21%) 
Metabolism and nutrition disorders     
Decreased appetite † 1     
# participants affected / at risk   16/47 (34.04%)   30/76 (39.47%) 
Hypokalaemia † 1     
# participants affected / at risk   2/47 (4.26%)   5/76 (6.58%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1     
# participants affected / at risk   7/47 (14.89%)   14/76 (18.42%) 
Back pain † 1     
# participants affected / at risk   12/47 (25.53%)   13/76 (17.11%) 
Bone pain † 1     
# participants affected / at risk   9/47 (19.15%)   6/76 (7.89%) 
Flank pain † 1     
# participants affected / at risk   3/47 (6.38%)   4/76 (5.26%) 
Muscular weakness † 1     
# participants affected / at risk   0/47 (0.00%)   6/76 (7.89%) 
Musculoskeletal chest pain † 1     
# participants affected / at risk   6/47 (12.77%)   6/76 (7.89%) 
Musculoskeletal pain † 1     
# participants affected / at risk   5/47 (10.64%)   4/76 (5.26%) 
Myalgia † 1     
# participants affected / at risk   15/47 (31.91%)   13/76 (17.11%) 
Pain in extremity † 1     
# participants affected / at risk   14/47 (29.79%)   15/76 (19.74%) 
Nervous system disorders     
Dizziness † 1     
# participants affected / at risk   10/47 (21.28%)   17/76 (22.37%) 
Dysgeusia † 1     
# participants affected / at risk   10/47 (21.28%)   19/76 (25.00%) 
Headache † 1     
# participants affected / at risk   17/47 (36.17%)   20/76 (26.32%) 
Hypoaesthesia † 1     
# participants affected / at risk   5/47 (10.64%)   4/76 (5.26%) 
Peripheral motor neuropathy † 1     
# participants affected / at risk   3/47 (6.38%)   1/76 (1.32%) 
Peripheral sensory neuropathy † 1     
# participants affected / at risk   22/47 (46.81%)   44/76 (57.89%) 
Somnolence † 1     
# participants affected / at risk   4/47 (8.51%)   1/76 (1.32%) 
Depression † 1     
# participants affected / at risk   5/47 (10.64%)   5/76 (6.58%) 
Insomnia † 1     
# participants affected / at risk   6/47 (12.77%)   15/76 (19.74%) 
Mood altered † 1     
# participants affected / at risk   1/47 (2.13%)   4/76 (5.26%) 
Psychiatric disorders     
Anxiety † 1     
# participants affected / at risk   3/47 (6.38%)   10/76 (13.16%) 
Renal and urinary disorders     
Urinary incontinence † 1     
# participants affected / at risk   0/47 (0.00%)   4/76 (5.26%) 
Reproductive system and breast disorders     
Breast pain † 1     
# participants affected / at risk   0/47 (0.00%)   4/76 (5.26%) 
Respiratory, thoracic and mediastinal disorders     
Cough † 1     
# participants affected / at risk   12/47 (25.53%)   18/76 (23.68%) 
Dysphonia † 1     
# participants affected / at risk   2/47 (4.26%)   4/76 (5.26%) 
Dyspnoea † 1     
# participants affected / at risk   10/47 (21.28%)   20/76 (26.32%) 
Dyspnoea exertional † 1     
# participants affected / at risk   3/47 (6.38%)   2/76 (2.63%) 
Epistaxis † 1     
# participants affected / at risk   10/47 (21.28%)   21/76 (27.63%) 
Nasal dryness † 1     
# participants affected / at risk   2/47 (4.26%)   7/76 (9.21%) 
Oropharyngeal pain † 1     
# participants affected / at risk   4/47 (8.51%)   7/76 (9.21%) 
Productive cough † 1     
# participants affected / at risk   3/47 (6.38%)   1/76 (1.32%) 
Rhinorrhoea † 1     
# participants affected / at risk   7/47 (14.89%)   7/76 (9.21%) 
Skin and subcutaneous tissue disorders     
Alopecia † 1     
# participants affected / at risk   29/47 (61.70%)   61/76 (80.26%) 
Dry skin † 1     
# participants affected / at risk   5/47 (10.64%)   6/76 (7.89%) 
Erythema † 1     
# participants affected / at risk   2/47 (4.26%)   6/76 (7.89%) 
Nail disorder † 1     
# participants affected / at risk   12/47 (25.53%)   20/76 (26.32%) 
Pruritus † 1     
# participants affected / at risk   4/47 (8.51%)   4/76 (5.26%) 
Rash † 1     
# participants affected / at risk   3/47 (6.38%)   14/76 (18.42%) 
Vascular disorders     
Hot flush † 1     
# participants affected / at risk   4/47 (8.51%)   11/76 (14.47%) 
Hypertension † 1     
# participants affected / at risk   1/47 (2.13%)   4/76 (5.26%) 
Lymphoedema † 1     
# participants affected / at risk   3/47 (6.38%)   2/76 (2.63%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 12.1



  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
No text entered.


  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:
unchecked 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.
unchecked 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.


Results Point of Contact:  
Name/Title: Anne McClain
Organization: Celgene Corporation
phone: 888-260-1599
e-mail: clinicaltrialdisclosure@celgene.com



Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00456846     History of Changes
Other Study ID Numbers: CA042
Study First Received: April 3, 2007
Results First Received: June 19, 2014
Last Updated: April 27, 2016
Health Authority: Canada: Health Canada
United States: Food and Drug Administration