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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 Participants With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive and Hormone Receptor-Positive Advanced Breast Cancer (PERTAIN)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01491737
First Posted: December 14, 2011
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This randomized, open-label, two-arm, multi-center, Phase II study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab plus an aromatase inhibitor (AI) in first-line participants with HER2-positive and hormone receptor-positive advanced breast cancer. Participants will be randomized to one of two treatment arms; Arm A (pertuzumab in combination with trastuzumab plus an AI) or Arm B (trastuzumab plus an AI). Participants may also receive induction chemotherapy (a taxane, either docetaxel or paclitaxel) at the investigator's discretion in combination with the assigned treatment arm. The anticipated time on study treatment is until disease progression, unacceptable toxicity, withdrawal of consent, or death whichever occurs first.

Condition Intervention Phase
Breast Cancer Drug: Pertuzumab Drug: Trastuzumab Drug: Aromatase Inhibitor Drug: Induction Chemotherapy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 (PFS) [ Time Frame: Baseline to progressive disease or death (approximately, up to 49 months) ]
    PFS is defined as the time from randomization until the first radiographically documented progression of disease or death from any cause, whichever occurred first (either during study treatment or during follow-up). Progression of disease was evaluated according to the response evaluation criteria in solid tumors (RECIST) (version 1.1). Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (Note: the appearance of one or more new lesions is also considered progression). Participants with no PFS events were censored at the time of the last evaluable tumor assessment.


Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: From the date of randomization until first documented death (approximately, up to 49 months) ]
    OS is defined as the time from the date of randomization to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last study medication (pertuzumab, trastuzumab, AI or induction chemotherapy), and participants with no post-baseline information were censored at the date of randomization.

  • Duration of Response (DOR) [ Time Frame: Baseline up to 49 months, approximately ]
    DOR was defined as the period from the date of initial confirmed partial response (PR) or complete response (CR) until the date of progressive disease or death from any cause. According to RECIST version 1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm; PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants with no documented progression after CR or PR were censored at the last date at which they were known to have had the CR or PR, respectively.

  • Time to Response (TTR) [ Time Frame: Baseline up to 49 months, approximately ]
    TTR was defined as the time from the date of randomization to the date of first CR or PR. According to RECIST version 1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm; PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. A censored time to response was calculated at the date of the last adequate tumor assessment as there was no date of confirmed response (CR or PR). If no tumor assessment is performed for the participant (or all post-baseline assessments are not evaluable or PD) the censoring day would be set to day 1 (date of randomization).

  • Objective Overall Response Rate (ORR) [ Time Frame: Baseline up to 49 months, approximately ]
    ORR was defined as participants with best (confirmed) overall response (BOR) of either CR or PR. ORR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, which is defined as best response recorded from start of study treatment until disease progression/recurrence or death. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm; PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference baseline sum diameters; SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Participants needed to have two consecutive assessments of PR or CR to be a responder. Only participants with measurable disease at baseline were included in the analysis of BOR and who did not have any evaluable post-baseline assessments were classified as not evaluable.

  • Clinical Benefit Response (CBR) [ Time Frame: Baseline up to 49 months, approximately ]
    CBR is percentage of participants with best (confirmed) PR or CR or SD for at least 6 months. According to RECIST version 1.1, CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm; PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

  • Change From Baseline in Health-Related Quality of Life as Determined by European Quality of Life 5-Dimension (EQ-5D) Visual Analog Scale (VAS) Scores [ Time Frame: Baseline, every 3 cycles (21-day cycle), and every 3 months after treatment discontinuation (up to 49 months, approximately) ]
    EQ-5D VAS: participant rated questionnaire to assess health-related quality of life (QoL) in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

  • Percentage of Participants With Any Adverse Event (AE) [ Time Frame: Up to 49 months approximately ]
    An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study and laboratory or clinical tests that resulted in a change in treatment or discontinuation from study drug were reported as adverse events.


Enrollment: 258
Actual Study Start Date: February 17, 2012
Estimated Study Completion Date: October 26, 2019
Primary Completion Date: March 17, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pertuzumab, Trastuzumab, AI or Induction Chemotherapy

Participants will receive pertuzumab in combination with trastuzumab plus AI until pre-defined study end, disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.

Participants may also receive induction chemotherapy (docetaxel every 3 weeks or paclitaxel weekly) up to the first 18-24 weeks of the treatment period at the investigator's discretion.

Drug: Pertuzumab
Participants will receive a loading dose of 840 milligrams (mg) as an intravenous infusion on Day 1 of first treatment cycle, followed by 420 mg on Day 1 or Day 2 of each subsequent 3-week cycle until disease progression or unacceptable toxicity.
Other Name: rhuMAb 2C4, Perjeta®
Drug: Trastuzumab
Participants will receive a loading dose of 8 milligrams per kilogram (mg/kg) as an intravenous infusion on Day 1 or 2 of first treatment cycle, followed by 6 mg/kg on Day 1 or Day 2 of each subsequent treatment 3-week cycles until disease progression or unacceptable toxicity.
Other Name: rhuMAb HER2, Herceptin®
Drug: Aromatase Inhibitor
Participants will receive 1 mg anastrozole or 2.5 mg letrozole orally once daily.
Drug: Induction Chemotherapy
Participants receiving induction chemotherapy up to the first 18-24 weeks of the treatment period will receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective pertuzumab and/or trastuzumab infusions at the investigator's discretion.
Active Comparator: Trastuzumab, AI or Induction Chemotherapy

Participants will receive trastuzumab plus AI until predefined study end, disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.

Participants may also receive induction chemotherapy (docetaxel every 3 weeks or paclitaxel weekly) up to the first 18-24 weeks of the treatment period at the investigator's discretion.

Drug: Trastuzumab
Participants will receive a loading dose of 8 milligrams per kilogram (mg/kg) as an intravenous infusion on Day 1 or 2 of first treatment cycle, followed by 6 mg/kg on Day 1 or Day 2 of each subsequent treatment 3-week cycles until disease progression or unacceptable toxicity.
Other Name: rhuMAb HER2, Herceptin®
Drug: Aromatase Inhibitor
Participants will receive 1 mg anastrozole or 2.5 mg letrozole orally once daily.
Drug: Induction Chemotherapy
Participants receiving induction chemotherapy up to the first 18-24 weeks of the treatment period will receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective pertuzumab and/or trastuzumab infusions at the investigator's discretion.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants 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 estrogen receptor-positive and/or progesterone receptor-positive
  • At least one measurable lesion and/or non-measurable disease evaluable according to Response Evaluation Criteria In Solid Tumors Version 1.1

Exclusion Criteria:

  • Previous systemic non-hormonal anticancer therapy in the metastatic or locally advanced breast cancer setting
  • 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
  • History of persistent Grade 2 or higher hematological toxicity according to National Cancer Institute-Common Toxicity Criteria Version 4.0
  • Disease-free interval from completion of adjuvant/neo-adjuvant systemic non-hormonal treatment to recurrence of within 6 months
  • Other malignancies within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma
  • Clinical or radiographic evidence of central nervous system metastases or significant cardiovascular disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01491737


  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
United States, Arizona
Ironwood Cancer TX & Rsch Ctrs
Chandler, Arizona, United States, 85224
United States, Arkansas
Genesis Cancer Center
Hot Springs, Arkansas, United States, 71913
United States, California
Comprehensive Blood & CA Ctr; Research
Bakersfield, California, United States, 93309
East Valley Hem/Onc Med Group; Metropolitan Hem Onc.
Burbank, California, United States, 91505
United States, Colorado
Rocky Mountain Cancer Center - Denver
Denver, Colorado, United States, 80220
United States, Connecticut
Norwalk Hospital
Norwalk, Connecticut, United States, 06856
United States, Florida
Advanced Medical Specialties
Miami, Florida, United States, 33176
United States, Georgia
Georgia Cancer Specialists - Northside
Atlanta, Georgia, United States, 30341
Northwest Georgia Oncology Centers
Marietta, Georgia, United States, 30060
United States, Kansas
Cancer Center of Kansas
Wichita, Kansas, United States, 67214-3728
United States, Louisiana
Crescent City Rsrch Cnsrtm, LLC
Marrero, Louisiana, United States, 70072
United States, Maryland
Weinberg CA Inst Franklin Sq
Baltimore, Maryland, United States, 21237
Center For Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
United States, Missouri
Washington University School of Medicine; Internal Medicine - Renal
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Hematology Oncology Associates; Carol G. Simon Ctr
Morristown, New Jersey, United States, 07960
Cooper Hospital; Hematology & Oncology
Voorhees, New Jersey, United States, 08043
United States, New York
NS-Long Island Jewish Hlth Sys
Lake Success, New York, United States, 11042
ProHEALTH Care Associates LLP
Lake Success, New York, United States, 11042
United States, Pennsylvania
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Baylor College of Medicine; Lester & Sue Smith Breast Ctr
Houston, Texas, United States, 77030
Scott and White Hospital; Cancer Center
Temple, Texas, United States, 76508
Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
Sao Paulo, SP, Brazil, 01246-000
Hospital Perola Byington
Sao Paulo, SP, Brazil, 01317-000
Inst. Brasileiro de Controle Ao Cancer; Oncologia Clinica / Quimioterapia
Sao Paulo, SP, Brazil, 03102-002
Hospital Sao Jose
São Paulo, SP, Brazil, CEP 01321-001
France
HOPITAL JEAN MINJOZ; Oncologie
Besancon, France, 25030
Clinique Tivoli; Sce Radiotherapie
Bordeaux, France, 33000
Clinique de La Cote D'Opale; Oncologie
Boulogne Sur Mer, France, 62222
Hopital Morvan; Oncologie - Radiotherapie
Brest, France, 29609
Centre Jean Perrin; Oncologie
Clermont Ferrand, France, 63011
Clinique De La Sauvegarde; Chimiotherapie
Lyon, France, 69337
Fondation Saint Joseph; Unite De Recherche Clinique
Marseille, France, 13285
Centre Catherine de Sienne; Chimiotherapie
Nantes, France, 44202
Centre Antoine Lacassagne; Hopital De Jour A2
Nice, France, 06189
CH De Senlis; Medecine 2
Senlis, France, 60309
Clinique Pasteur; Oncologie Medicale
Toulouse, France, 31076
Centre Alexis Vautrin; Oncologie Medicale
Vandoeuvre Les Nancy, France, 54511
India
Indraprastha Apollo Hospitals
New Delhi, Delhi, India, 110076
Bangalore Institute of Oncology
Bangalore, Karnataka, India, 560027
Jaslok Hospital & Research Centre; Medical Oncology
Mumbai, Maharashtra, India, 400026
Apollo Speciality Hospital
Chennai, India, 600035
Ruby Hall Clinic
Pune, India, 411 001
Italy
Az. Osp. Cardarelli; Divisione Di Oncologia
Napoli, Campania, Italy, 80131
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, Campania, Italy, 80131
Università degli Studi Federico II; Clinica di Oncologia Medica
Napoli, Campania, Italy, 80131
Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
Bologna, Emilia-Romagna, Italy, 40138
Ospedale Regionale Di Parma; Divisione Di Oncologia Medica
Parma, Emilia-Romagna, Italy, 43100
A.O. Santa Maria Degli Angeli; U.O Di Oncologia Medica
Pordenone, Friuli-Venezia Giulia, Italy, 33170
Ospedale S.S. Trinità Nuovo; Divisione Oncologia
Sora, Lazio, Italy, 03039
Az. Osp. Spedali Civili; Divisione Di Oncologia - Iii Medicina
Brescia, Lombardia, Italy, 25123
Casa di Cura MultiMedica Ospedale di Castellanza; UO Senologia Medica
Castellanza, Lombardia, Italy, 21053
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
Milano, Lombardia, Italy, 20133
IRCCS Fondazione Maugeri; Oncologia Medica I
Pavia, Lombardia, Italy, 27100
Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
Bari, Puglia, Italy, 70124
Ospedale Antonio Perrino; Oncologia Medica
Brindisi, Puglia, Italy, 72100
Ospedale Vito Fazzi; Div. Oncoematologia
Lecce, Puglia, Italy, 73100
Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica
Catania, Sicilia, Italy, 95122
A.O. Careggi; Radioterapia
Firenze, Toscana, Italy, 50139
Ospedale Misericordia E Dolce; Oncologia Medica
Prato, Toscana, Italy, 59100
Ospedale Santa Chiara; Oncologia Medica
Trento, Trentino-Alto Adige, Italy, 38100
Ospedale Di Vicenza; Nefrologia, Oncologia Medica
Vicenza, Veneto, Italy, 36100
Spain
IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia
San Sebastian, Guipuzcoa, Spain, 20014
Hospital de Donostia; Servicio de Oncologia Medica
San Sebastian, Guipuzcoa, Spain, 20080
Hospital del Mar; Servicio de Oncologia
Barcelona, Spain, 08003
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Barcelona, Spain, 08916
Hospital de San Pedro de Alcantara
Caceres, Spain, 10003
Hospital Provincial de Castellon; Servicio de Oncologia
Castellon, Spain, 12002
Hospital Universitario Reina Sofia; Servicio de Oncologia
Cordoba, Spain, 14004
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
La Coruña, Spain, 15006
Centro Oncológico Gallego José Antonio Quiroga y Piñeiro, Servicio de Oncologia
La Coruña, Spain, 15009
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia
Lerida, Spain, 25198
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid, Spain, 28034
Hospital Universitario Clínico San Carlos; Servicio de Oncologia
Madrid, Spain, 28040
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
Murcia, Spain, 30120
Hospital Universitario Virgen Macarena; Servicio de Oncologia
Sevilla, Spain, 41009
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, Spain, 46010
Hospital Universitario Miguel Servet; Servicio Oncologia
Zaragoza, Spain, 50009
Turkey
Ankara Numune Hospital; Onkoloji
Ankara, Turkey, 06100
Ankara Oncology Hospital; Oncology
Ankara, Turkey, 06200
Kartal Training and Research Hospital;Medical Oncology Department
Istanbul, Turkey, 34000
Ege Uni Medical Faculty Hospital; Oncology Dept
Izmir, Turkey, 35100
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
Malatya, Turkey, 44280
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Sıhhiye, ANKARA, Turkey, 06100
Karadeniz Tecnical University Medical Faculty; Oncology Department
Trabzon, Turkey, 61080
United Kingdom
Brighton and Sussex Univ Hosp
Brighton, United Kingdom, BN2 5BE
Broomfield Hospital
Chelmsford, United Kingdom, CM1 7ET
University Hospital coventry; Oncology Department
Coventry, United Kingdom, CV2 2DX
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
Queen Elizabeth Hospital
London, United Kingdom, SE18 4QH
Queen Alexandra Hospital, Portsmouth
Portsmouth, United Kingdom, PO6 3LY
Scarborough General Hospital
Scarborough, United Kingdom, YO12 6QL
Weston Park Hospital; Cancer Clinical Trials Centre
Sheffield, United Kingdom, S10 2SJ
Great Western Hospital; Clinical Oncology
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
2011-002132-10 ( EudraCT Number )
First Submitted: December 6, 2011
First Posted: December 14, 2011
Results First Submitted: May 11, 2017
Results First Posted: June 7, 2017
Last Update Posted: September 11, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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