A Study of Pertuzumab in Combination With Trastuzumab (Herceptin) and a Taxane in First-Line Treatment in Participants With Human Epidermal Growth Factor 2 (HER2)-Positive Advanced Breast Cancer (PERUSE)

Study Description

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Brief Summary:

This multicenter, open-label, single-arm, Phase IIIb study will evaluate the safety and tolerability of pertuzumab in combination with trastuzumab (Herceptin) and a taxane (docetaxel, paclitaxel or nab-paclitaxel) in first-line treatment in participants with metastatic or locally recurrent HER2-positive breast cancer. Participants will receive pertuzumab intravenously (IV) and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first.

Condition or disease	Intervention/treatment	Phase
Breast Neoplasms	Drug: Docetaxel; Drug: Nab-paclitaxel; Drug: Paclitaxel; Drug: Pertuzumab; Drug: Trastuzumab	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1436 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Multicenter, Open-Label, Single-Arm Study of Pertuzumab in Combination With Trastuzumab and a Taxane in First Line Treatment of Patients With HER2-Positive Advanced (Metastatic or Locally Recurrent) Breast Cancer
Actual Study Start Date :	June 1, 2012
Estimated Primary Completion Date :	September 28, 2019
Estimated Study Completion Date :	September 28, 2019

Arms and Interventions

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Arm

Intervention/treatment

Experimental: Pertuzumab + Trastuzumab + Taxane; Participants will receive pertuzumab and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first. Taxane chemotherapy can be either docetaxel, paclitaxel or nab-paclitaxel as per investigator's choice.

Drug: Docetaxel; Participants may receive 'docetaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.; Drug: Nab-paclitaxel; Participants may receive 'nab-paclitaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.; Drug: Paclitaxel; Participants may receive 'paclitaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.; Drug: Pertuzumab; Participants will receive pertuzumab 840 milligrams (mg) IV on Day 1 or Day 2 of Cycle 1, followed by 420 mg IV on Day 1 or Day 2 of each subsequent 3-week cycle.; Other Name: RO 43-68451; Drug: Trastuzumab; Participants will receive trastuzumab (Herceptin) 8 milligrams per kilogram (mg/kg) IV on Day 1 or Day 2 of Cycle 1, followed by 6 mg/kg IV on Day 1 or Day 2 of each subsequent 3-week cycle, administered in line with the respective product Information and/or recognized clinical practice guidelines.; Other Name: Herceptin

Outcome Measures

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Primary Outcome Measures :

1. Percentage of Participants With AEs Leading to Study Treatment Interruption and Discontinuation [ Time Frame: Baseline up to approximately 7 years 3 months ]
2. Percentage of Participants who Died, Reported by Cause of Death [ Time Frame: Baseline up to approximately 7 years 3 months ]
3. Percentage of Participants with Congestive Heart Failure (CHF) [ Time Frame: Baseline up to approximately 7 years 3 months ]
4. Percentage of Participants with Adverse Events (AEs) and Serious AEs (SAEs) [ Time Frame: Baseline up to approximately 7 years 3 months ]
5. Left Ventricular Ejection Fraction (LVEF) Values Over the Course of the Study [ Time Frame: Screening, every 3 cycles (cycle length=3 weeks) prior to study drug administration during treatment period, 1 month post-treatment safety follow-up (approximately 7 years 3 months overall) ]
6. Time to Onset of the First Episode of CHF [ Time Frame: Baseline up to approximately 7 years 3 months ]

Secondary Outcome Measures :

1. Progression-Free Survival (PFS) as Assessed by Investigator Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 [ Time Frame: Screening up to disease progression or death (event) (assessed every 3 cycles [cycle length = 3 weeks] up to 36 months, and every 6 cycles thereafter until event occurrence or end of study, whichever occurs first up to approximately 7 years 3 months) ]
2. Overall Survival [ Time Frame: Screening up to death due to any cause (up to approximately 7 years 3 months) ]
3. Percentage of Participants with Objective Response (Complete Response [CR] or Partial Response [PR]) Based on Best Confirmed Overall Response as Assessed by Investigator Based on RECIST v1.1 [ Time Frame: Screening up to disease progression or death (event) (assessed every 3 cycles [cycle length = 3 weeks] up to 36 months, and every 6 cycles thereafter until event occurrence or end of study, whichever occurs first up to approximately 7 years 3 months) ]
4. Percentage of Response with Clinical Benefit Response (CR, PR or Stable Disease [SD; for At Least 6 months] Based on Best Confirmed Overall Response as Assessed by Investigator Based on RECIST v.1.1 [ Time Frame: Screening up to disease progression or death (event) (assessed every 3 cycles [cycle length = 3 weeks] up to 36 months, and every 6 cycles thereafter until event occurrence or end of study, whichever occurs first up to approximately 7 years 3 months) ]
5. Duration of Response as Assessed by Investigator Based on RECIST v1.1 [ Time Frame: Screening up to disease progression or death (event) (assessed every 3 cycles [cycle length = 3 weeks] up to 36 months, and every 6 cycles thereafter until event occurrence or end of study, whichever occurs first up to approximately 7 years 3 months) ]
6. Time to Response Among Participants with Best Response of PR or CR as Assessed by Investigator Based on RECIST v1.1 [ Time Frame: Screening up to disease progression or death (event) (assessed every 3 cycles [cycle length = 3 weeks] up to 36 months, and every 6 cycles thereafter until event occurrence or end of study, whichever occurs first up to approximately 7 years 3 months) ]
7. Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores for Female Participants Only [ Time Frame: Screening, every 3 cycles (cycle length=3 weeks) during treatment period, 1 and 3 months post-treatment safety follow-up (approximately 7 years 3 months overall) ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection
• HER2-positive breast cancer
• Eastern cooperative Oncology Group (ECOG) performance status 0, 1 or 2
• LVEF of at least 50 percent (%)

Exclusion Criteria:

• Previous systemic non-hormonal anti-cancer therapy for metastatic or locally recurrent disease
• Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence less than or equal to (</=) 6 months
• Previous approved or investigative anti-HER2 agents in any breast cancer treatment setting, except for trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
• Disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
• History of persistent Grade 2 or higher (National Cancer Institute Common Toxicity Criteria [NCI-CTC], Version 4.0) hematological toxicity resulting from previous adjuvant or neoadjuvant therapy
• Central nervous system (CNS) metastases
• Current peripheral neuropathy of Grade 3 or greater (NCI-CTC, version 4.0)
• History of other malignancy within the last 5 years prior to first study drug administration, except for carcinoma in situ of the cervix or basal cell carcinoma
• Inadequate bone marrow, liver or renal function
• Uncontrolled hypertension
• Hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) infection

Contacts and Locations

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  Show 325 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:	Clinical Trials	Hoffmann-La Roche

More Information

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Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01572038 History of Changes
Other Study ID Numbers:	MO28047; 2011-005334-20 ( EudraCT Number )
First Posted:	April 5, 2012
Last Update Posted:	January 8, 2019
Last Verified:	January 2019

Additional relevant MeSH terms:

Pertuzumab; Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Paclitaxel; Docetaxel; Taxane	Albumin-Bound Paclitaxel; Trastuzumab; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action