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Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer (SOPHIA)

This study is currently recruiting participants.
Verified December 2017 by MacroGenics
Sponsor:
ClinicalTrials.gov Identifier:
NCT02492711
First Posted: July 9, 2015
Last Update Posted: December 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
MacroGenics
July 6, 2015
July 9, 2015
December 11, 2017
July 2015
March 2020   (Final data collection date for primary outcome measure)
  • Progression-free survival (PFS) as determined by independent radiological review. [ Time Frame: Approximately 41 months after the first subject is randomized; anticipated evaluation Dec 2018 ]
  • Overall survival (OS) defined as the number of days from randomization to the date of death (from any cause). [ Time Frame: Approximately 15 months after the last subject is randomized; anticipated evaluation Mar 2020 ]
    Overall survival of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in patients with advanced HER2+ breast cancer.
  • Progression-free survival as determined by independent radiological review. [ Time Frame: PFS will be evaluated 24 months from the start of the study ]
  • Overall survival defined as the number of days from randomization to the date of death (from any cause). [ Time Frame: OS will be evaluated 36 months from the start of the study ]
    Overall survival (OS) of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in patients with advanced HER2+ breast cancer.
Complete list of historical versions of study NCT02492711 on ClinicalTrials.gov Archive Site
  • To evaluate progression-free survival (PFS), as assessed by study investigators. [ Time Frame: PFS will be evaluated approximately 41 months after the first subject is randomized. ]
  • To evaluate the objective response rate (ORR) as determined by independent radiological review. [ Time Frame: ORR will be evaluated approximately 41 months after the first subject is randomized. ]
  • To evaluate progression-free survival (PFS), as assessed by study investigators. [ Time Frame: PFS will be evaluated 24 months from the start of the study ]
  • To evaluate the objective response rate (ORR) as determined by independent radiological review. [ Time Frame: ORR will be evaluated 36 months from the start of the study ]
Not Provided
Not Provided
 
Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer
A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Patients With HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies and Require Systemic Treatment
The purpose of this study is to determine whether patients treated with margetuximab plus chemotherapy have longer progression free survival and overall survival than patients treated with trastuzumab plus chemotherapy.
An evaluation of efficacy, as measured by progression-free survival (PFS) assessed by independent review and overall survival (OS), of margetuximab plus chemotherapy compared with trastuzumab plus chemotherapy in patients with advanced HER2+ breast cancer who have received at least 2 prior lines of anti-HER2 directed therapy in the metastatic setting, or in case of having received (neo)adjuvant pertuzumab, at least 1 prior line of anti-HER2 directed therapy in the metastatic setting, and who have received at least one, and no more than three, lines of therapy overall in the metastatic setting.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • HER-2 Positive Breast Cancer
  • Metastatic Neoplasm
  • Biological: Margetuximab
    15 mg/kg via IV (intravenous) infusion over 120 minutes on day 1 of each 21 day cycle, until progression or unacceptable toxicity develops.
  • Biological: Trastuzumab
    8 mg/kg via IV (intravenous) infusion for the first dose and 6 mg/kg for all subsequent doses via IV infusion over 30-90 minutes on day 1 of each 21 day cycle, until progression or unacceptable toxicity develops.
    Other Name: Herceptin®
  • Drug: Capecitabine
    1000 mg/m2 BID for 14 days in a 21-day cycle
    Other Name: Xeloda®
  • Drug: Eribulin
    1.4 mg/m2 on days 1 and 8 of a 21-day cycle
    Other Name: Halaven®
  • Drug: Gemcitabine
    1000 mg/m2 on days 1 and 8 of a 21-day cycle
    Other Name: Gemzar ®
  • Drug: Vinorelbine
    25-30 mg/m2 on days 1 and 8 of a 21-day cycle
    Other Name: Navelbine®
  • Experimental: Margetuximab plus chemotherapy
    Margetuximab 15 mg/kg every 21 days plus Capecitabine 1000 mg/m2 BID for 14 days in a 21-day cycle or Eribulin 1.4 mg/m2 Day 1 and 8 of a 21-day cycle or Gemcitabine 1000 mg/m2 Day 1 and 8 of a 21-day cycle or Vinorelbine 25-30 mg/m2 Day 1 and 8 of a 21-day cycle
    Interventions:
    • Biological: Margetuximab
    • Drug: Capecitabine
    • Drug: Eribulin
    • Drug: Gemcitabine
    • Drug: Vinorelbine
  • Active Comparator: Trastuzumab plus chemotherapy
    Trastuzumab 8 mg/kg loading dose then 6 mg/kg every 21 days plus Capecitabine 1000 mg/m2 BID for 14 days in a 21-day cycle or Eribulin 1.4 mg/m2 Day 1 and 8 of a 21-day cycle or Gemcitabine 1000 mg/m2 Day 1 and 8 of a 21-day cycle or Vinorelbine 25-30 mg/m2 Day 1 and 8 of a 21-day cycle
    Interventions:
    • Biological: Trastuzumab
    • Drug: Capecitabine
    • Drug: Eribulin
    • Drug: Gemcitabine
    • Drug: Vinorelbine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
530
March 2021
March 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically-proven metastatic or locally-advanced relapsed/refractory HER2+ breast cancer based on the most recently available tumor biopsy collected from the patient. Tumors may be estrogen receptor (ER)/progesterone receptor (PgR) positive or negative.
  • Have received at least 2 prior lines of anti-HER2 directed therapy in the metastatic setting, or in case of having received (neo)adjuvant pertuzumab, at least 1 prior line of anti-HER2 directed therapy in the metastatic setting. In either case, patients must have received prior treatment with pertuzumab, in the (neo)adjuvant or metastatic setting. Prior radiotherapy, hormonal therapies, and other anti-HER2 therapies are allowed.
  • Prior treatment with at least one, and no more than three, lines of therapy overall in the metastatic setting. Patients must have progressed on or following, the most recent line of therapy.
  • Resolution of all chemotherapy or radiation-related toxicities to ≤ Grade 1
  • Life expectancy ≥ 12 weeks
  • Acceptable laboratory parameters
  • Women of childbearing potential must have negative pregnancy test performed within 14 days of randomization and on the first day of treatment. All subjects must agree to use an effective form of contraception for the duration of study treatment and for 7 months after the last dose of study drug.

Exclusion Criteria:

  • Known, untreated brain metastasis. Patients with signs or symptoms of brain metastasis must have a CT or MRI performed within 4 weeks prior to randomization to specifically exclude the presence of radiographically-detected brain metastases
  • History of uncontrolled seizures within 6 months of randomization
  • History of prior allogeneic bone marrow, stem-cell, or solid organ transplantation
  • History of clinically significant cardiovascular disease
  • Clinically-significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation
  • Any condition that would be a contraindication to receiving trastuzumab as described in the approved local label or a condition that would prevent treatment with the physician's choice of chemotherapy
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Sutton Edlich (240) 552-8082
Austria,   Belgium,   Canada,   Czechia,   Denmark,   Finland,   France,   Germany,   Israel,   Italy,   Korea, Republic of,   Netherlands,   Portugal,   Puerto Rico,   Spain,   United Kingdom,   United States
Czech Republic
 
NCT02492711
CP-MGAH22-04
Yes
Not Provided
Plan to Share IPD: Undecided
MacroGenics
MacroGenics
Not Provided
Study Director: Edwin Rock, MD PhD MacroGenics
MacroGenics
December 2017

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