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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02019277
First received: December 18, 2013
Last updated: November 1, 2016
Last verified: November 2016

December 18, 2013
November 1, 2016
December 2013
November 2016   (final data collection date for primary outcome measure)
  • Percentage of Participants With Adverse Events (AEs), Serious AEs, and AEs Leading to Premature Discontinuation [ Time Frame: Baseline up to 36 months ] [ Designated as safety issue: No ]
  • Percentage of Participants With Cardiac AEs [ Time Frame: Baseline up to 36 months ] [ Designated as safety issue: Yes ]
  • Percentage of Participants with Congestive Heart Failure (CHF), According to NCI CTCAE Version 4.0 and New York Heart Association Classification (NYHA) [ Time Frame: Baseline up to 36 months ] [ Designated as safety issue: Yes ]
  • Percentage of Participants with Asymptomatic Decline in Left Ventricular Ejection Fraction (LVEF), Assessed Using Echocardiography (ECHO) or Multiple-gated Acquisition (MUGA) Scan [ Time Frame: Baseline up to 28 days after last dose (up to 36 months) ] [ Designated as safety issue: Yes ]
  • Incidence of adverse events (AEs) [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  • Incidence of serious AEs [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  • Evidence of cardiac dysfunction as measured by decreases in left ventricular ejection fraction (LVEF). [ Time Frame: Up to 24 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT02019277 on ClinicalTrials.gov Archive Site
  • Percentage of Participants with Best Overall Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: Baseline up to 36 months ] [ Designated as safety issue: No ]
  • Progression-free Survival Assessed According to RECIST Version 1.1 [ Time Frame: Baseline up to 36 months ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Baseline up to 36 months ] [ Designated as safety issue: No ]
  • Event-free Survival Assessed According to RECIST Version 1.1 [ Time Frame: Baseline up to 36 months ] [ Designated as safety issue: No ]
  • Percentage of Participants Receiving Second-Line Treatment [ Time Frame: Baseline up to 36 months ] [ Designated as safety issue: No ]
  • Overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  • Progression-free Survival Assessed According to RECIST Version 1.1 [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  • Event-free Survival Assessed According to RECIST Version 1.1 [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Pertuzumab and Trastuzumab Treatment in Combination With a Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer
An Open-label, Multicentre, Phase IIIb Study With Intravenous Administration of Pertuzumab, Subcutaneous Trastuzumab, and a Taxane in Patients With HER2-positive Metastatic Breast Cancer (SAPPHIRE)
This open-label, multicenter, phase IIIb study will assess the safety, tolerability and efficacy of a combination therapy of intravenous (IV) pertuzumab (Perjeta), subcutaneous (SC) trastuzumab (Herceptin), 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 per 5 milliliter [mg/5 mL]). 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. Time on study treatment is up to 2 years.
Not Provided
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: Docetaxel
    Dosing regimen to be determined by the investigator, routine clinical practices.
  • Drug: Nab-paclitaxel
    Dosing regimen to be determined by the investigator, routine clinical practices.
  • Drug: Paclitaxel
    Dosing regimen to be determined by the investigator, routine clinical practices.
  • 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 intravenous infusion every 3 weeks.
    Other Name: Perjeta
  • Drug: Trastuzumab
    Trastuzumab will be administered at a fixed dose of 600 milligrams (mg) per 5 milliliter (mL) subcutaneously every 3 weeks.
    Other Name: Herceptin
Experimental: Trastuzumab, 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.
Interventions:
  • Drug: Docetaxel
  • Drug: Nab-paclitaxel
  • Drug: Paclitaxel
  • Drug: Pertuzumab
  • Drug: Trastuzumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
November 2016
November 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT02019277
ML28784
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP