A Study of Pertuzumab and Trastuzumab Subcutaneous (SC) Treatment in Combination With a Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer

NCT ID: NCT02019277

Last Updated: 2018-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-05
• Study Completion Date: 2016-11-04

Brief Summary

This open-label, multicenter, Phase IIIb study will assess the safety, tolerability and efficacy of a combination therapy of intravenous (IV) pertuzumab (Perjeta), trastuzumab (Herceptin) SC, and taxane chemotherapy (docetaxel, paclitaxel or nab-paclitaxel) as first-line therapy in participants with HER2-positive metastatic breast cancer (mBC). All participants will be treated with 3-week cycles of pertuzumab IV (840 milligrams [mg] first dose; subsequent doses of 420 mg) and trastuzumab SC (600 milligrams [mg]). The taxane treatment regimen will be determined by the investigator. Participants will continue therapy until disease progression, unacceptable toxicity, or the participant withdraws consent, whichever occurs first.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Trastuzumab SC, Pertuzumab, and Taxane

Participants will receive pertuzumab, trastuzumab and a taxane (docetaxel, paclitaxel or nab-paclitaxel) once every 3 weeks (21-day cycles). Choice of taxane will be at the discretion of the investigator and administered per routine clinical practices and local prescribing instructions.

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

Dosing regimen to be determined by the investigator, routine clinical practices.

Nab-paclitaxel

Intervention Type: DRUG

Dosing regimen to be determined by the investigator, routine clinical practices.

Paclitaxel

Intervention Type: DRUG

Dosing regimen to be determined by the investigator, routine clinical practices.

Pertuzumab

Intervention Type: DRUG

Pertuzumab will be administered on Day 1 of the first treatment cycle as a loading dose of 840 mg, followed by 420 mg as an IV infusion every 3 weeks.

Trastuzumab

Intervention Type: DRUG

Trastuzumab will be administered at a fixed dose of 600 mg SC every 3 weeks.

Interventions

Docetaxel

Dosing regimen to be determined by the investigator, routine clinical practices.

Intervention Type: DRUG

Nab-paclitaxel

Dosing regimen to be determined by the investigator, routine clinical practices.

Intervention Type: DRUG

Paclitaxel

Dosing regimen to be determined by the investigator, routine clinical practices.

Intervention Type: DRUG

Pertuzumab

Pertuzumab will be administered on Day 1 of the first treatment cycle as a loading dose of 840 mg, followed by 420 mg as an IV infusion every 3 weeks.

Intervention Type: DRUG

Trastuzumab

Trastuzumab will be administered at a fixed dose of 600 mg SC every 3 weeks.

Intervention Type: DRUG

Other Intervention Names

Perjeta; Herceptin

Eligibility Criteria

Inclusion Criteria

• HER2-positive disease, with an immunohistochemistry score of 3+ or in situ hybridization (ISH)-positive on primary tumor or metastatic site
• Histologically or cytologically confirmed adenocarcinoma of the breast with metastatic disease with at least one measurable lesion and/or non-measurable disease according to RECIST Version 1.1
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2 for participants who will receive paclitaxel or nab-paclitaxel chemotherapy and ECOG 0-1 for participants who will receive docetaxel chemotherapy
• LVEF of greater than or equal to (>=) 50 percent (%) measured by ECHO or MUGA scan before the first doses of pertuzumab and trastuzumab
• Previous use of either adjuvant or neoadjuvant anti-HER2 therapy is allowed
• Hormonal therapy will be allowed as per institutional guidelines. Hormonal therapy cannot be administered in combination with taxane therapy

Exclusion Criteria

• Previous systemic non-hormonal anticancer therapy for treatment of mBC
• History of other cancers. Participants with curatively treated carcinoma in situ of the cervix or basal cell carcinoma and participants with other curatively-treated cancers who have been disease-free for at least 5 years are eligible. Participants with previous ductal carcinoma in situ (DCIS) of the breast are also eligible for the study
• Pregnant or breastfeeding women. Positive serum pregnancy test in women of childbearing potential, premenopausal or less than 12 months of amenorrhea post-menopause, within 7 days before the first dose of pertuzumab and trastuzumab
• Current peripheral neuropathy of Grade 3 or greater (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version 4.0)
• Radiographic evidence of central nervous system (CNS) metastases as assessed by computed tomography (CT) or magnetic resonance imaging (MRI), unless they have been treated and have been stable for at least 3 months and do not require ongoing corticosteroid treatment
• Participants with other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness
• Inadequate organ function
• Serious cardiac illness or medical conditions that would preclude the use of trastuzumab
• Participants with severe dyspnea at rest or requiring supplementary oxygen therapy
• Concurrent enrollment in another clinical study using an investigational anti-cancer treatment, within 28 days before the first doses of trastuzumab and pertuzumab

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

St George Hospital; Cancer Care Centre

Kogarah, New South Wales, Australia

Port Macquarie Base Hospital

Port Macquarie, New South Wales, Australia

Newcastle Mater Misericordiae Hospital; Oncology

Waratah, New South Wales, Australia

Mater Hospital; Cancer Services

South Brisbane, Queensland, Australia

Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology

Woolloongabba, Queensland, Australia

Lyell McEwin Hospital

Adelaide, South Australia, Australia

Launceston General Hospital

Launceston, Tasmania, Australia

Bendigo Hospital; Oncology

Bendigo, Victoria, Australia

Monash Medical Centre; Oncology

Clayton, Victoria, Australia

Geelong Hospital; Andrew Love Cancer Centre

Geelong, Victoria, Australia

Royal Melbourne Hospital; Hematology and Medical Oncology

Parkville, Victoria, Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

St John of God Murdoch Hospital; Oncology West

Murdoch, Western Australia, Australia

Countries

Australia

References

Woodward N, De Boer RH, Redfern A, White M, Young J, Truman M, Beith J. Results From the First Multicenter, Open-label, Phase IIIb Study Investigating the Combination of Pertuzumab With Subcutaneous Trastuzumab and a Taxane in Patients With HER2-positive Metastatic Breast Cancer (SAPPHIRE). Clin Breast Cancer. 2019 Jun;19(3):216-224. doi: 10.1016/j.clbc.2019.02.008. Epub 2019 Feb 27.

Reference Type: DERIVED

PMID: 30922805 (View on PubMed)

Other Identifiers

ML28784

Identifier Type: -

Identifier Source: org_study_id