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)

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Pertuzumab; Drug: Trastuzumab; Drug: Aromatase Inhibitor; Drug: Induction Chemotherapy

• Study Type: Interventional
• Enrollment (Actual): 258
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 01246-000
      • Instituto do Cancer do Estado de Sao Paulo - ICESP
    • Sao Paulo, SP, Brazil, 03102-002
      • Inst. Brasileiro de Controle Ao Cancer; Oncologia Clinica / Quimioterapia
    • Sao Paulo, SP, Brazil, 01317-904
      • Hospital Perola Byington
    • São Paulo, SP, Brazil, CEP 01321-001
      • Hospital Sao Jose
• France
  • Besancon, France, 25030
    • HOPITAL JEAN MINJOZ; Oncologie
  • Bordeaux, France, 33000
    • Clinique Tivoli; Sce Radiotherapie
  • Brest, France, 29609
    • Hopital Morvan; Oncologie - Radiotherapie
  • Clermont Ferrand, France, 63011
    • Centre Jean Perrin; Oncologie
  • Lyon, France, 69337
    • Clinique De La Sauvegarde; Chimiotherapie
  • Nantes, France, 44202
    • Centre Catherine de Sienne; Chimiotherapie
  • Nice, France, 06189
    • Centre Antoine Lacassagne; Hopital De Jour A2
  • Senlis, France, 60309
    • CH De Senlis; Medecine 2
  • Toulouse, France, 31076
    • Clinique Pasteur; Oncologie Medicale
  • Vandoeuvre-les-nancy, France, 54519
    • Centre Alexis Vautrin; Oncologie Medicale
• India
  • Chennai, India, 600035
    • Apollo Speciality Hospital
  • Pune, India, 411 001
    • Ruby Hall Clinic
  • Delhi
    • New Delhi, Delhi, India, 110076
      • Indraprastha Apollo Hospitals
  • Karnataka
    • Bangalore, Karnataka, India, 560027
      • Bangalore Institute of Oncology
  • Maharashtra
    • Mumbai, Maharashtra, India, 400026
      • Jaslok Hospital & Research Centre; Medical Oncology
• Italy
  • Campania
    • Napoli, Campania, Italy, 80131
      • Istituto Nazionale Tumori Fondazione G. Pascale
    • Napoli, Campania, Italy, 80131
      • Università degli Studi Federico II; Clinica di Oncologia Medica
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
    • Parma, Emilia-Romagna, Italy, 43100
      • Ospedale Regionale Di Parma; Divisione Di Oncologia Medica
  • Friuli-Venezia Giulia
    • Pordenone, Friuli-Venezia Giulia, Italy, 33170
      • A.O. Santa Maria Degli Angeli; U.O Di Oncologia Medica
  • Lazio
    • Sora, Lazio, Italy, 03039
      • Ospedale S.S. Trinità Nuovo; Divisione Oncologia
  • Lombardia
    • Castellanza, Lombardia, Italy, 21053
      • Casa di Cura MultiMedica Ospedale di Castellanza; UO Senologia Medica
    • Milano, Lombardia, Italy, 20133
      • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
    • Pavia, Lombardia, Italy, 27100
      • IRCCS Fondazione Maugeri; Oncologia Medica I
  • Puglia
    • Bari, Puglia, Italy, 70124
      • Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
    • Brindisi, Puglia, Italy, 72100
      • Ospedale Antonio Perrino; Oncologia Medica
    • Lecce, Puglia, Italy, 73100
      • Ospedale Vito Fazzi; Div. Oncoematologia
  • Sicilia
    • Catania, Sicilia, Italy, 95122
      • Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica
  • Toscana
    • Firenze, Toscana, Italy, 50139
      • A.O. Careggi; Radioterapia
    • Prato, Toscana, Italy, 59100
      • Ospedale Misericordia E Dolce; Oncologia Medica
• Spain
  • Barcelona, Spain, 08003
    • Hospital del Mar; Servicio de Oncologia
  • Caceres, Spain, 10003
    • Hospital de San Pedro de Alcantara
  • La Coruña, Spain, 15006
    • Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
  • La Coruña, Spain, 15009
    • Centro Oncológico Gallego José Antonio Quiroga y Piñeiro, Servicio de Oncologia
  • Lerida, Spain, 25198
    • Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia
  • Madrid, Spain, 28034
    • Hospital Ramon y Cajal; Servicio de Oncologia
  • Madrid, Spain, 28040
    • Hospital Universitario Clínico San Carlos; Servicio de Oncologia
  • Murcia, Spain, 30120
    • Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena; Servicio de Oncologia
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet; Servicio Oncologia
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
  • Castellon
    • Castellon de La Plana, Castellon, Spain, 12002
      • Hospital Provincial de Castellon; Servicio de Oncologia
  • Cordoba
    • Córdoba, Cordoba, Spain, 14004
      • Hospital Universitario Reina Sofia; Servicio de Oncologia
  • Guipuzcoa
    • San Sebastian, Guipuzcoa, Spain, 20080
      • Hospital de Donostia; Servicio de Oncologia Medica
    • San Sebastian, Guipuzcoa, Spain, 20014
      • IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia
• Turkey
  • Ankara, Turkey, 06490
    • Ankara City Hospital
  • Ankara, Turkey, 06100
    • Hacettepe Uni Medical Faculty Hospital; Oncology Dept
  • Izmir, Turkey, 35100
    • Ege Uni Medical Faculty Hospital; Oncology Dept
  • Malatya, Turkey, 44280
    • Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department
• United Kingdom
  • Brighton, United Kingdom, BN2 5BE
    • Brighton and Sussex Univ Hosp
  • Coventry, United Kingdom, CV2 2DX
    • University Hospital coventry; Oncology Department
  • Glasgow, United Kingdom, G12 0YN
    • Beatson West of Scotland Cancer Centre
  • London, United Kingdom, SE18 4QH
    • Queen Elizabeth Hospital
  • Portsmouth, United Kingdom, PO6 3LY
    • Queen Alexandra Hospital, Portsmouth
  • Scarborough, United Kingdom, YO12 6QL
    • Scarborough General Hospital
  • Sheffield, United Kingdom, S10 2SJ
    • Weston Park Hospital; Cancer Clinical Trials Centre
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • University of Alabama at Birmingham
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Ironwood Cancer TX & Rsch Ctrs
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Genesis Cancer Center
  • California
    • Bakersfield, California, United States, 93309
      • Comprehensive Blood & CA Ctr; Research
  • Colorado
    • Denver, Colorado, United States, 80220
      • Rocky Mountain Cancer Center - Denver
  • Connecticut
    • Norwalk, Connecticut, United States, 06856
      • Norwalk Hospital
  • Florida
    • Miami, Florida, United States, 33176
      • Advanced Medical Specialties
  • Georgia
    • Atlanta, Georgia, United States, 30341
      • Georgia Cancer Specialists - Northside
    • Marietta, Georgia, United States, 30060
      • Northwest Georgia Oncology Centers, a Service of WellStar Cobb Hospital
  • Kansas
    • Wichita, Kansas, United States, 67214-3728
      • Cancer Center of Kansas
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Crescent City Rsrch Cnsrtm, LLC
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Weinberg CA Inst Franklin Sq
    • Bethesda, Maryland, United States, 20817
      • Center for Cancer and Blood Disorders
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine; Internal Medicine - Renal
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Hematology Oncology Associates; Carol G. Simon Ctr
    • Voorhees, New Jersey, United States, 08043
      • Cooper Hospital; Hematology & Oncology
  • New York
    • Lake Success, New York, United States, 11042
      • ProHEALTH Care Associates LLP
    • Lake Success, New York, United States, 11042
      • NS-Long Island Jewish Hlth Sys
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Cancer Centers
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine; Lester & Sue Smith Breast Ctr
    • Temple, Texas, United States, 76508
      • Scott and White Hospital; Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm A: Pertuzumab + Trastuzumab + AI +/- Chemotherapy; Participants will receive pertuzumab in combination with trastuzumab plus aromatase inhibitor (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 Names: 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 Names: 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: Arm B: Trastuzumab + AI +/- Chemotherapy; Participants will receive trastuzumab plus aromatase inhibitor (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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	Progression-free survival (PFS) was 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 and 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). The sum of target lesion diameters 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. The primary analysis of PFS was planned to be performed when a total of 165 PFS events had occurred, and the final analysis after at least 60 months follow-up.	Median [full range] of follow-up time on study for: Primary Analysis: 31.7 [0.0-44.3] months vs. 30.4 [0.0-45.8] months in Arm A vs. Arm B; Final Analysis: 73.20 [0.03-88.34] months vs. 71.06 [0.03-88.97] months in Arm A vs. Arm B

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Overall survival (OS) was 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. The primary analysis of OS was planned to be performed at the same time as for PFS (when a total of 165 PFS events had occurred), and the final analysis was planned after at least 60 months follow-up for all participants.	Median [full range] of follow-up time on study for: Primary Analysis: 31.7 [0.0-44.3] months vs. 30.4 [0.0-45.8] months in Arm A vs. Arm B; Final Analysis: 73.20 [0.03-88.34] months vs. 71.06 [0.03-88.97] months in Arm A vs. Arm B
Overall Response Rate (ORR)	The overall response rate (ORR) was defined as the percentage of participants with best (confirmed) overall response (BOR) of either complete response (CR) or partial response (PR) from start of study treatment until progressive disease (PD)/recurrence or death, as assessed by the investigator 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 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. Participants needed to have two consecutive assessments of PR or CR at least 4 weeks apart to be a responder. Analysis of this outcome measure was only planned to occur at the time of primary analysis.	Median [full range] of follow-up time on study for Primary Analysis: 31.7 [0.0-44.3] months vs. 30.4 [0.0-45.8] months in Arm A vs. Arm B
Clinical Benefit Rate (CBR)	Clinical Benefit Rate (CBR) was defined as the percentage of participants with best (confirmed) partial response (PR) or complete response (CR) or stable disease (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; 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. Analysis of this outcome measure was only planned to occur at the time of primary analysis.	Median [full range] of follow-up time on study for Primary Analysis: 31.7 [0.0-44.3] months vs. 30.4 [0.0-45.8] months in Arm A vs. Arm B
Duration of Response (DOR)	Duration of response (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. The primary analysis of DOR was planned to be performed at the same time as for PFS (when a total of 165 PFS events had occurred), and the final analysis was planned after at least 60 months follow-up for all participants.	Median [full range] of follow-up time on study for: Primary Analysis: 31.7 [0.0-44.3] months vs. 30.4 [0.0-45.8] months in Arm A vs. Arm B; Final Analysis: 73.20 [0.03-88.34] months vs. 71.06 [0.03-88.97] months in Arm A vs. Arm B
Time to Response (TTR)	Time to Response (TTR) was defined as the time from the date of randomization to the date of first complete response (CR) or partial response (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. For participants who did not have a confirmed response, a censored TTR was calculated at the date of the last adequate tumor assessment. 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). Analysis of this outcome measure was only planned to occur at the time of primary analysis.	Median [full range] of follow-up time on study for Primary Analysis: 31.7 [0.0-44.3] months vs. 30.4 [0.0-45.8] months in Arm A vs. Arm B
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	The EQ-5D VAS is a 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.	Baseline and every 3 cycles until treatment discontinuation (up to Cycle 120; 1 cycle is 21 days)
Overview of the Number of Participants With Adverse Events, Severity Determined According to NCI-CTCAE Version 4.03	All adverse events (AEs) occurring during the study and until the post-treatment safety follow-up visit approximately 28 days after last study medication were recorded; thereafter, only study drug-related serious adverse events (SAEs) continued to be collected. The investigator graded all AEs for severity per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03; if not listed, the AE was assessed as follows: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening/disabling; Grade 5 = death. The investigator determined whether an AE was related to study drug and independently assessed severity and seriousness of each AE. AEs suggestive of congestive heart failure (CHF) were identified by the SMQ (wide) "Cardiac Failure" with a status of "serious", which included the preferred terms cardiac failure, left ventricular dysfunction, and pulmonary oedema.	From Baseline until the end of post-treatment follow-up (up to 89 months)
Number of Participants Who Died Over the Course of the Study by Reported Cause of Death and Time of Death Relative to First or Last Dose of Study Treatment	The causes of death over the course of the study, regardless of whether the death was related to study treatment, are listed by preferred term according to the Medical Dictionary for Regulatory Activities (MedDRA), version 22.1.	From Baseline until the end of post-treatment follow-up (up to 89 months)
Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study	Left ventricular ejection fraction (LVEF) is the measurement of how much blood is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction. A normal LVEF ranges from 55% to 70%, as measured by echocardiogram or multiple-gated acquisition (MUGA) scan. All participants must have had a baseline LVEF of at least (≥)50% to enroll in the study; patients with clinically significant cardiovascular disease or baseline LVEF below 50% were not eligible for this study.	Baseline and every 3 cycles until treatment discontinuation (up to Cycle 120; 1 cycle is 21 days)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• Rimawi M, Ferrero JM, de la Haba-Rodriguez J, Poole C, De Placido S, Osborne CK, Hegg R, Easton V, Wohlfarth C, Arpino G; PERTAIN Study Group. First-Line Trastuzumab Plus an Aromatase Inhibitor, With or Without Pertuzumab, in Human Epidermal Growth Factor Receptor 2-Positive and Hormone Receptor-Positive Metastatic or Locally Advanced Breast Cancer (PERTAIN): A Randomized, Open-Label Phase II Trial. J Clin Oncol. 2018 Oct 1;36(28):2826-2835. doi: 10.1200/JCO.2017.76.7863. Epub 2018 Aug 14.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 17, 2012
• Primary Completion (ACTUAL): March 17, 2016
• Study Completion (ACTUAL): November 14, 2019

Study Registration Dates

• First Submitted: December 6, 2011
• First Submitted That Met QC Criteria: December 12, 2011
• First Posted (ESTIMATE): December 14, 2011

Study Record Updates

• Last Update Posted (ACTUAL): October 28, 2020
• Last Update Submitted That Met QC Criteria: October 6, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Immunological; Hormone Antagonists; Steroid Synthesis Inhibitors; Estrogen Antagonists; Trastuzumab; Pertuzumab; Aromatase Inhibitors
• Other Study ID Numbers: MO27775; 2011-002132-10 (EUDRACT_NUMBER)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No