Trial record 1 of 1 for:    NCT01491737
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A Study of Pertuzumab in Combination With Trastuzumab Plus an Aromatase Inhibitor in Patients With Hormone Receptor-Positive, Metastatic HER2-positive Breast Cancer

This study is currently recruiting participants.
Verified April 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01491737
First received: December 6, 2011
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

This randomized, open-label, 2-arm, multi-center, phase II study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab (Herceptin) plus an aromatase inhibitor in first-line patients with HER2-positive and hormone receptor-positive advanced breast cancer. Patients will be randomized to one of two treatment arms: Arm 1: pertuzumab plus trastuzumab plus aromatase inhibitor, Arm 2: trastuzumab plus aromatase inhibitor. At the investigator's discretion, patients may also receive induction chemotherapy (a taxane, either docetaxel or paclitaxel). The anticipated time on study treatment is until disease progression or unacceptable toxicity.


Condition Intervention Phase
Breast Cancer
Drug: pertuzumab
Drug: trastuzumab
Drug: Aromatase Inhibitor
Drug: Induction Chemotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Two-arm, Open-label, Multicenter Phase II Trial Assessing the Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab Plus an Aromatase Inhibitor in First Line Patients With HER2-positive and Hormone Receptor-positive Advanced (Metastatic or Locally Advanced) Breast Cancer.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free Survival [ Time Frame: Up to approximately 33 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: Up to approximately 49 months ] [ Designated as safety issue: No ]
  • Overall Response Rate [ Time Frame: Up to approximately 49 months ] [ Designated as safety issue: No ]
  • Clinical Benefit Rate [ Time Frame: Up to approximately 49 months ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: Up to approximately 49 months ] [ Designated as safety issue: No ]
  • Time to Response [ Time Frame: Up to approximately 49 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of Adverse Events [ Time Frame: Up to approximately 49 months ] [ Designated as safety issue: No ]
  • Quality of Life: EQ-5D Questionnaire [ Time Frame: Up to approximately 49 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: February 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: pertuzumab
Loading dose of 840 mg intravenously on Day 1 of first treatment cycle, followed by 420 mg on Day 1 of each subsequent 3-weeks cycle. Until disease progression or unacceptable toxicity.
Drug: trastuzumab
Loading dose of 8 mg/kg intravenously on Day 1 of first treatment cycle, followed by 6 mg/kg on Day 1 of each subsequent treatment 3-weeks cycles. Until disease progression or unacceptable toxicity.
Drug: Aromatase Inhibitor
1 mg anastrozole or 2.5 mg letrozole orally once daily
Drug: Induction Chemotherapy
At the investigator's discretion, patients may also receive induction chemotherapy, either docetaxel or paclitaxel.
Active Comparator: 2 Drug: trastuzumab
Loading dose of 8 mg/kg intravenously on Day 1 of first treatment cycle, followed by 6 mg/kg on Day 1 of each subsequent treatment 3-weeks cycles. Until disease progression or unacceptable toxicity.
Drug: Aromatase Inhibitor
1 mg anastrozole or 2.5 mg letrozole orally once daily
Drug: Induction Chemotherapy
At the investigator's discretion, patients may also receive induction chemotherapy, either docetaxel or paclitaxel.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female adult patients, >/=18 years of age
  • Patients with HER2-positive and hormone receptor-positive advanced metastatic or locally advanced breast cancer
  • Post-menopausal status over 1 year
  • HER2-positive as assessed by local laboratory on primary or metastatic tumor
  • Hormone-receptor positive defined as ER-positive and/or PgR-positive
  • At least one measurable lesion and/or non-measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST)

Exclusion Criteria:

  • Previous treatment with anti-HER2 agents for breast cancer, except trastuzumab and/or lapatinib in the neoadjuvant or adjuvant setting
  • Disease progression while receiving adjuvant trastuzumab and/or lapatinib treatment
  • Disease-free interval from completion of adjuvant/neo-adjuvant systemic non-hormonal treatment to recurrence of within 6 months
  • Other malignancies in </= 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma
  • Clinical or radiographic evidence of central nervous system (CNS) metastases or significant CV disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01491737

Contacts
Contact: Reference Study ID Number: MO27775 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Hide Study Locations
Locations
United States, Alabama
Recruiting
Birmingham, Alabama, United States, 35249
United States, Arizona
Recruiting
Chandler, Arizona, United States, 85224
United States, Arkansas
Active, not recruiting
Hot Springs, Arkansas, United States, 71913
United States, California
Recruiting
Bakersfield, California, United States, 93309
Recruiting
Burbank, California, United States, 91505
United States, Colorado
Recruiting
Denver, Colorado, United States, 80220
United States, Connecticut
Recruiting
Norwalk, Connecticut, United States, 06856
United States, Florida
Recruiting
Miami, Florida, United States, 33176
United States, Georgia
Recruiting
Atlanta, Georgia, United States, 30341
Recruiting
Marietta, Georgia, United States, 30060
United States, Kansas
Recruiting
Wichita, Kansas, United States, 67214-3728
United States, Louisiana
Recruiting
Marrero, Louisiana, United States, 70072
United States, Maryland
Completed
Baltimore, Maryland, United States, 21237
Recruiting
Bethesda, Maryland, United States, 20817
United States, Missouri
Recruiting
St. Louis, Missouri, United States, 63110
United States, New Jersey
Completed
Morristown, New Jersey, United States, 07960
Recruiting
Voorhees, New Jersey, United States, 08043
United States, New York
Recruiting
Lake Success, New York, United States, 11042
Completed
Lake Success, New York, United States, 11042
United States, Pennsylvania
Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Recruiting
Houston, Texas, United States, 77030
Recruiting
Temple, Texas, United States, 76508
Brazil
Active, not recruiting
Sao Paulo, SP, Brazil, 01317-000
Active, not recruiting
Sao Paulo, SP, Brazil, 01246-000
Recruiting
Sao Paulo, SP, Brazil, 03102-002
Recruiting
Sao Paulo, SP, Brazil, 01321-001
France
Recruiting
Besancon, France, 25030
Recruiting
Bordeaux, France, 33000
Recruiting
Boulogne Sur Mer, France, 62222
Recruiting
Brest, France, 29609
Recruiting
Clermont Ferrand, France, 63011
Recruiting
Lyon, France, 69337
Recruiting
Marseille, France, 13285
Recruiting
Nantes, France, 44202
Recruiting
Nice, France, 06189
Recruiting
Senlis, France, 60309
Recruiting
Toulouse, France, 31076
Recruiting
Vandoeuvre Les Nancy, France, 54511
India
Recruiting
Bangalore, India, 560027
Recruiting
Chennai, India, 600035
Recruiting
Mumbai, India, 400026
Recruiting
New Delhi, India, 110076
Recruiting
Pune, India, 411 001
Italy
Active, not recruiting
Napoli, Campania, Italy, 80131
Terminated
Napoli, Campania, Italy, 80131
Recruiting
Bologna, Emilia-Romagna, Italy, 40138
Recruiting
Parma, Emilia-Romagna, Italy, 43100
Active, not recruiting
Pordenone, Friuli-Venezia Giulia, Italy, 33170
Active, not recruiting
Sora, Lazio, Italy, 03039
Terminated
Brescia, Lombardia, Italy, 25123
Active, not recruiting
Castellanza, Lombardia, Italy, 21053
Active, not recruiting
Milano, Lombardia, Italy, 20133
Completed
Pavia, Lombardia, Italy, 27100
Active, not recruiting
Bari, Puglia, Italy, 70124
Active, not recruiting
Brindisi, Puglia, Italy, 72100
Active, not recruiting
Lecce, Puglia, Italy, 73100
Completed
Catania, Sicilia, Italy, 95122
Recruiting
Firenze, Toscana, Italy, 50139
Active, not recruiting
Prato, Toscana, Italy, 59100
Terminated
Trento, Trentino-Alto Adige, Italy, 38100
Terminated
Vicenza, Veneto, Italy, 36100
Spain
Recruiting
San Sebastian, Guipuzcoa, Spain, 20014
Recruiting
San Sebastian, Guipuzcoa, Spain, 20080
Recruiting
La Coruna, La Coruña, Spain, 15009
Active, not recruiting
Barcelona, Spain, 08003
Recruiting
Barcelona, Spain, 08916
Active, not recruiting
Caceres, Spain, 10310
Active, not recruiting
Castellon, Spain, 12002
Active, not recruiting
Cordoba, Spain, 14004
Active, not recruiting
La Coruña, Spain, 15006
Recruiting
Lerida, Spain, 25198
Recruiting
Madrid, Spain, 28040
Recruiting
Madrid, Spain, 28034
Recruiting
Murcia, Spain, 30120
Recruiting
Sevilla, Spain, 41009
Recruiting
Valencia, Spain, 46010
Recruiting
Zaragoza, Spain, 50009
Turkey
Terminated
Ankara, Turkey, 06200
Recruiting
Ankara, Turkey, 06100
Terminated
Istanbul, Turkey, 34000
Recruiting
Izmir, Turkey, 35100
Recruiting
Malatya, Turkey, 44280
Recruiting
S?hhiye, ANKARA, Turkey, 06100
Terminated
Trabzon, Turkey, 61080
United Kingdom
Recruiting
Brighton, United Kingdom, BN2 5BE
Recruiting
Chelmsford, United Kingdom, CM1 7ET
Recruiting
Coventry, United Kingdom, CV2 2DX
Recruiting
Glasgow, United Kingdom, G12 0YN
Recruiting
London, United Kingdom, SE18 4QH
Recruiting
Portsmouth, United Kingdom, PO6 3LY
Recruiting
Scarborough, United Kingdom, YO12 6QL
Recruiting
Sheffield, United Kingdom, S10 2SJ
Recruiting
Swindon, United Kingdom, SN3 6BB
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01491737     History of Changes
Other Study ID Numbers: MO27775
Study First Received: December 6, 2011
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Aromatase Inhibitors
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014