A Phase 3 Study of Margetuximab Plus Chemotherapy vs Trastuzumab plus Chemotherapy in the Treatment of Patients with HER2+ Metastatic Breast Cancer (SOPHIA).

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 624

Inclusion Criteria

1. Male or female patients = 18 years of age.
2. Have 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 (PR) positive or negative.
3. 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.
4. Have received treatment with at least one, and no more than three, lines of therapy overall in the metastatic setting.
5. Resolution of all chemotherapy or radiation-related toxicities to = Grade 1 (with exception of = Grade 2 alopecia, stable sensory neuropathy, or stable electrolyte disturbances that are managed by supplementation).
6. Have life expectancy = 12 weeks.
7. Have acceptable laboratory parameters.
8. Female patients of childbearing potential must have negative pregnancy test performed within 14 days of randomization and a negative serum or urine pregnancy test and on the day of first study treatment. All subjects must agree to use highly effective contraceptive measures.
Inclusion Criteria for the Infusion Sub-Study:
1. Patients will meet all entry criteria for the randomized portion of the study with the exception of inclusion criteria #3 and #4 above (which correspond to #4 and #5 in the Protocol).
2. Patients must have received at least 4 prior lines of therapy for metastatic disease. Hormonal therapies will not be considered when determining the number of previous lines of therapy in the metastatic setting.
Prior neo-adjuvant or adjuvant therapy that resulted in relapse within 6 months of the completion of therapy will be considered a line of treatment for metastatic disease. Eligible patients must have progressed on or following the most recent line of therapy. Dose interruptions, delays, pauses during previous therapy, or changes in therapy to
manage toxicity will not constitute a new line of therapy provided disease progression did not occur.
3. Patients must have received prior trastuzumab, pertuzumab, and TDM1.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 450
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 158

Exclusion Criteria

1. Patients with 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-detectable brain metastases.
2. History of uncontrolled seizures within 6 months of randomization.
3. History of prior allogeneic bone marrow, stem-cell, or solid organ transplantation.
4. History of clinically significant cardiovascular disease.
5. Clinically-significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation.
6. 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Updated 4/19/2022

A Phase 3 Study of Margetuximab Plus Chemotherapy vs Trastuzumab plus Chemotherapy in the Treatment of Patients with HER2+ Metastatic Breast Cancer (SOPHIA).

Recruitment & Eligibility

Study & Design

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