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

Phase 1

• Conditions: Metastatic or Locally Advanced HER2-positive Breast Cancer; MedDRA version: 18.1Level: PTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 18.1Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 18.1Level: LLTClassification code 10072740Term: Locally advanced breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-000380-13-FR
• Lead Sponsor: MacroGenics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-04
• Last Update Posted: 13 June 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 530

Inclusion Criteria

1. Male or female patients = 18 years of age.
2. Have histologically-proven metastatic or locally-advanced relapsed/refractory HER2+ breast cancer. Tumors may be estrogen receptor (ER)/progesterone receptor (PR) positive or negative.
3. Have received prior treatment with pertuzumab, trastuzumab, and ado-trastuzumab emtansine in the neoadjuvant, adjuvant, or metastatic setting. Prior radiotherapy and hormonal therapies are allowed.
4. Have received treatment for at least one, and no more than two, lines of therapy in the metastatic setting. Prior neo-adjuvant or adjuvant therapy that resulted in relapse within 6 months of 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.
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. All subjects should practice effective contraception.

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 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 130

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.
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 chemotherapies.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified