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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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01491737
First received: December 6, 2011
Last updated: September 1, 2016
Last verified: September 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 ]

Enrollment: 258
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

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35249
United States, Arizona
Chandler, Arizona, United States, 85224
United States, Arkansas
Hot Springs, Arkansas, United States, 71913
United States, California
Bakersfield, California, United States, 93309
Burbank, California, United States, 91505
United States, Colorado
Denver, Colorado, United States, 80220
United States, Connecticut
Norwalk, Connecticut, United States, 06856
United States, Florida
Miami, Florida, United States, 33176
United States, Georgia
Atlanta, Georgia, United States, 30341
Marietta, Georgia, United States, 30060
United States, Kansas
Wichita, Kansas, United States, 67214-3728
United States, Louisiana
Marrero, Louisiana, United States, 70072
United States, Maryland
Baltimore, Maryland, United States, 21237
Bethesda, Maryland, United States, 20817
United States, Missouri
St. Louis, Missouri, United States, 63110
United States, New Jersey
Morristown, New Jersey, United States, 07960
Voorhees, New Jersey, United States, 08043
United States, New York
Lake Success, New York, United States, 11042
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Houston, Texas, United States, 77030
Temple, Texas, United States, 76508
Brazil
Sao Paulo, SP, Brazil, 01246-000
Sao Paulo, SP, Brazil, 01317-000
Sao Paulo, SP, Brazil, 03102-002
São Paulo, SP, Brazil, CEP 01321-001
France
Besancon, France, 25030
Bordeaux, France, 33000
Boulogne Sur Mer, France, 62222
Brest, France, 29609
Clermont Ferrand, France, 63011
Lyon, France, 69337
Marseille, France, 13285
Nantes, France, 44202
Nice, France, 06189
Senlis, France, 60309
Toulouse, France, 31076
Vandoeuvre Les Nancy, France, 54511
India
New Delhi, Delhi, India, 110076
Bangalore, Karnataka, India, 560027
Mumbai, Maharashtra, India, 400026
Chennai, India, 600035
Pune, India, 411 001
Italy
Napoli, Campania, Italy, 80131
Bologna, Emilia-Romagna, Italy, 40138
Parma, Emilia-Romagna, Italy, 43100
Pordenone, Friuli-Venezia Giulia, Italy, 33170
Sora, Lazio, Italy, 03039
Brescia, Lombardia, Italy, 25123
Castellanza, Lombardia, Italy, 21053
Milano, Lombardia, Italy, 20133
Pavia, Lombardia, Italy, 27100
Bari, Puglia, Italy, 70124
Brindisi, Puglia, Italy, 72100
Lecce, Puglia, Italy, 73100
Catania, Sicilia, Italy, 95122
Firenze, Toscana, Italy, 50139
Prato, Toscana, Italy, 59100
Trento, Trentino-Alto Adige, Italy, 38100
Vicenza, Veneto, Italy, 36100
Spain
San Sebastian, Guipuzcoa, Spain, 20014
San Sebastian, Guipuzcoa, Spain, 20080
Barcelona, Spain, 08003
Barcelona, Spain, 08916
Caceres, Spain, 10003
Castellon, Spain, 12002
Cordoba, Spain, 14004
La Coruña, Spain, 15006
La Coruña, Spain, 15009
Lerida, Spain, 25198
Madrid, Spain, 28034
Madrid, Spain, 28040
Murcia, Spain, 30120
Sevilla, Spain, 41009
Valencia, Spain, 46010
Zaragoza, Spain, 50009
Turkey
Ankara, Turkey, 06100
Ankara, Turkey, 06200
Istanbul, Turkey, 34000
Izmir, Turkey, 35100
Malatya, Turkey, 44280
Sıhhiye, ANKARA, Turkey, 06100
Trabzon, Turkey, 61080
United Kingdom
Brighton, United Kingdom, BN2 5BE
Chelmsford, United Kingdom, CM1 7ET
Coventry, United Kingdom, CV2 2DX
Glasgow, United Kingdom, G12 0YN
London, United Kingdom, SE18 4QH
Portsmouth, United Kingdom, PO6 3LY
Scarborough, United Kingdom, YO12 6QL
Sheffield, United Kingdom, S10 2SJ
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: September 1, 2016
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 26, 2016