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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. (see Contacts and Locations)
Verified November 2016 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01491737
First received: December 6, 2011
Last updated: November 1, 2016
Last verified: November 2016
  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: Aromatase Inhibitor
Drug: Induction Chemotherapy
Drug: pertuzumab
Drug: trastuzumab
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: October 2019
Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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.
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.
Active Comparator: 2 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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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. and Canada) global.rochegenentechtrials@roche.com

  Hide Study Locations
Locations
United States, Alabama
Completed
Birmingham, Alabama, United States, 35249
United States, Arizona
Active, not recruiting
Chandler, Arizona, United States, 85224
United States, Arkansas
Completed
Hot Springs, Arkansas, United States, 71913
United States, California
Active, not recruiting
Bakersfield, California, United States, 93309
Terminated
Burbank, California, United States, 91505
United States, Colorado
Recruiting
Denver, Colorado, United States, 80220
United States, Connecticut
Active, not recruiting
Norwalk, Connecticut, United States, 06856
United States, Florida
Active, not recruiting
Miami, Florida, United States, 33176
United States, Georgia
Active, not recruiting
Atlanta, Georgia, United States, 30341
Active, not recruiting
Marietta, Georgia, United States, 30060
United States, Kansas
Active, not recruiting
Wichita, Kansas, United States, 67214-3728
United States, Louisiana
Active, not recruiting
Marrero, Louisiana, United States, 70072
United States, Maryland
Completed
Baltimore, Maryland, United States, 21237
Active, not recruiting
Bethesda, Maryland, United States, 20817
United States, Missouri
Active, not recruiting
St. Louis, Missouri, United States, 63110
United States, New Jersey
Completed
Morristown, New Jersey, United States, 07960
Completed
Voorhees, New Jersey, United States, 08043
United States, New York
Completed
Lake Success, New York, United States, 11042
United States, Pennsylvania
Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Active, not recruiting
Houston, Texas, United States, 77030
Active, not recruiting
Temple, Texas, United States, 76508
Brazil
Active, not recruiting
Sao Paulo, SP, Brazil, 01246-000
Active, not recruiting
Sao Paulo, SP, Brazil, 01317-000
Active, not recruiting
Sao Paulo, SP, Brazil, 03102-002
Active, not recruiting
São Paulo, SP, Brazil, CEP 01321-001
France
Active, not recruiting
Besancon, France, 25030
Completed
Bordeaux, France, 33000
Terminated
Boulogne Sur Mer, France, 62222
Active, not recruiting
Brest, France, 29609
Completed
Clermont Ferrand, France, 63011
Active, not recruiting
Lyon, France, 69337
Terminated
Marseille, France, 13285
Active, not recruiting
Nantes, France, 44202
Active, not recruiting
Nice, France, 06189
Active, not recruiting
Senlis, France, 60309
Completed
Toulouse, France, 31076
Active, not recruiting
Vandoeuvre Les Nancy, France, 54511
India
Active, not recruiting
New Delhi, Delhi, India, 110076
Active, not recruiting
Bangalore, Karnataka, India, 560027
Active, not recruiting
Mumbai, Maharashtra, India, 400026
Completed
Chennai, India, 600035
Recruiting
Pune, India, 411 001
Italy
Active, not recruiting
Napoli, Campania, Italy, 80131
Terminated
Napoli, Campania, Italy, 80131
Completed
Bologna, Emilia-Romagna, Italy, 40138
Active, not 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
Completed
Milano, Lombardia, Italy, 20133
Completed
Pavia, Lombardia, Italy, 27100
Active, not recruiting
Bari, Puglia, Italy, 70124
Active, not recruiting
Brindisi, Puglia, Italy, 72100
Completed
Lecce, Puglia, Italy, 73100
Completed
Catania, Sicilia, Italy, 95122
Active, not 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
Completed
San Sebastian, Guipuzcoa, Spain, 20080
Active, not recruiting
Barcelona, Spain, 08003
Active, not recruiting
Barcelona, Spain, 08916
Active, not recruiting
Caceres, Spain, 10003
Completed
Castellon, Spain, 12002
Active, not recruiting
Cordoba, Spain, 14004
Active, not recruiting
La Coruña, Spain, 15006
Active, not recruiting
La Coruña, Spain, 15009
Active, not recruiting
Lerida, Spain, 25198
Active, not recruiting
Madrid, Spain, 28034
Completed
Madrid, Spain, 28040
Completed
Murcia, Spain, 30120
Active, not recruiting
Sevilla, Spain, 41009
Completed
Valencia, Spain, 46010
Active, not recruiting
Zaragoza, Spain, 50009
Turkey
Active, not recruiting
Ankara, Turkey, 06100
Terminated
Ankara, Turkey, 06200
Terminated
Istanbul, Turkey, 34000
Active, not recruiting
Izmir, Turkey, 35100
Active, not recruiting
Malatya, Turkey, 44280
Active, not recruiting
Sıhhiye, ANKARA, Turkey, 06100
Terminated
Trabzon, Turkey, 61080
United Kingdom
Completed
Brighton, United Kingdom, BN2 5BE
Terminated
Chelmsford, United Kingdom, CM1 7ET
Active, not recruiting
Coventry, United Kingdom, CV2 2DX
Completed
Glasgow, United Kingdom, G12 0YN
Active, not recruiting
London, United Kingdom, SE18 4QH
Active, not recruiting
Portsmouth, United Kingdom, PO6 3LY
Active, not recruiting
Scarborough, United Kingdom, YO12 6QL
Active, not recruiting
Sheffield, United Kingdom, S10 2SJ
Terminated
Swindon, United Kingdom, SN3 6BB
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

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: November 1, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pertuzumab
Trastuzumab
Hormones
Aromatase Inhibitors
Antineoplastic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists

ClinicalTrials.gov processed this record on December 02, 2016