A Study of Pertuzumab in Combination With Trastuzumab Plus an Aromatase Inhibitor in Participants With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive and Hormone Receptor-Positive Advanced Breast Cancer (PERTAIN)

Roche

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Pertuzumab; Drug: Trastuzumab; Drug: Aromatase Inhibitor; Drug: Induction Chemotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01491737

MO27775

2011-002132-10 (EudraCT Number)

Details and patient eligibility

About

This randomized, open-label, two-arm, multi-center, Phase II study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab plus an aromatase inhibitor (AI) in first-line participants with HER2-positive and hormone receptor-positive advanced breast cancer. Participants will be randomized to one of two treatment arms; Arm A (pertuzumab in combination with trastuzumab plus an AI) or Arm B (trastuzumab plus an AI). Participants may also receive induction chemotherapy (a taxane, either docetaxel or paclitaxel) at the investigator's discretion in combination with the assigned treatment arm. The anticipated time on study treatment is until disease progression, unacceptable toxicity, withdrawal of consent, or death whichever occurs first.

Enrollment: 258 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with HER2-positive and hormone receptor-positive advanced metastatic or locally advanced breast cancer
• Post-menopausal status over 1 year
• HER2-positive as assessed by local laboratory on primary or metastatic tumor
• Hormone-receptor positive defined as estrogen receptor-positive and/or progesterone receptor-positive
• At least one measurable lesion and/or non-measurable disease evaluable according to Response Evaluation Criteria In Solid Tumors Version 1.1

Exclusion criteria

• Previous systemic non-hormonal anticancer therapy in the metastatic or locally advanced breast cancer setting
• Previous treatment with anti-HER2 agents for breast cancer, except trastuzumab and/or lapatinib in the neoadjuvant or adjuvant setting
• Disease progression while receiving adjuvant trastuzumab and/or lapatinib treatment
• History of persistent Grade 2 or higher hematological toxicity according to National Cancer Institute-Common Toxicity Criteria Version 4.0
• Disease-free interval from completion of adjuvant/neo-adjuvant systemic non-hormonal treatment to recurrence of within 6 months
• Other malignancies within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma
• Clinical or radiographic evidence of central nervous system metastases or significant cardiovascular disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

258 participants in 2 patient groups

Arm A: Pertuzumab + Trastuzumab + AI +/- Chemotherapy

Experimental group

Description:

Participants will receive pertuzumab in combination with trastuzumab plus aromatase inhibitor (AI) until pre-defined study end, disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first. Participants may also receive induction chemotherapy (docetaxel every 3 weeks or paclitaxel weekly) up to the first 18-24 weeks of the treatment period at the investigator's discretion.

Treatment:

Drug: Induction Chemotherapy

Drug: Aromatase Inhibitor

Drug: Trastuzumab

Drug: Pertuzumab

Arm B: Trastuzumab + AI +/- Chemotherapy

Active Comparator group

Description:

Participants will receive trastuzumab plus aromatase inhibitor (AI) until predefined study end, disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first. Participants may also receive induction chemotherapy (docetaxel every 3 weeks or paclitaxel weekly) up to the first 18-24 weeks of the treatment period at the investigator's discretion.

Treatment:

Drug: Induction Chemotherapy

Drug: Aromatase Inhibitor

Drug: Trastuzumab