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

Status:	Active, not recruiting
Conditions:	Breast Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	2/2/2019
Start Date:	February 17, 2012
End Date:	October 26, 2019

A Randomized, Two-Arm, Open-Label, Multicenter Phase II Trial Assessing the Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab Plus an Aromatase Inhibitor in First Line Patients With HER2-Positive and Hormone Receptor-Positive Advanced (Metastatic or Locally Advanced) Breast Cancer

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.

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

We found this trial at

sites

Norwalk Hospital

Norwalk, Connecticut 06856

from

Norwalk, CT