HER2-Targeted Therapy for Breast Cancer

Recruiting at 192 trial locations

Overseen By Jack Beranek

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Alliance for Clinical Trials in Oncology

Must be taking: HER2-targeted therapy

Must not be taking: Investigational anti-cancer agents

Disqualifiers: Stage IV cancer, Inadequate cardiac function, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 27

Duration: 6-12 months

1524 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase III trial compares 6 months of human epidermal growth factor receptor 2 (HER2)-targeted therapy to 12 months of HER2-targeted therapy for the treatment of HER2-positive (+) breast cancer in patients that had a pathologic complete response (pCR) after preoperative (neoadjuvant) chemotherapy with trastuzumab. Trastuzumab and pertuzumab are monoclonal antibodies and forms of targeted therapy that attach to a receptor protein called HER2. HER2 is found on some cancer cells. When trastuzumab or pertuzumab attach to HER2, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving 6 months of HER2-targeted therapy may work better than giving 12 months for the treatment of HER2+ breast cancer in patients that had a pCR after neoadjuvant chemotherapy with trastuzumab.

Who Is on the Research Team?

Adrienne Waks, MD

Principal Investigator

Alliance for Clinical Trials in Oncology

Are You a Good Fit for This Trial?

This trial is for men and women with HER2+ breast cancer who had no invasive disease left after pre-surgery chemo with trastuzumab. They must have clinical stage T1c-T3, N0-N1 (except T3N1), ECOG status 0-2, received specific neoadjuvant therapy durations, and can't have isolated tumor cells in nodes.

Inclusion Criteria

Both of my breasts had invasive cancer and both met the study's requirements, including HER2+.

I completed at least 12 weeks of chemo with trastuzumab, possibly with pertuzumab, before surgery.

My breast cancer is at a specific stage and has not spread extensively to lymph nodes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive trastuzumab and possibly pertuzumab every 21 days for up to 17 cycles (12 months) or 9 cycles (6 months), depending on the arm

6-12 months

Every 21 days

Follow-up

Participants are monitored for recurrence-free survival and quality of life, with follow-ups every 6 months for 5 years, then annually up to 10 years

10 years

Every 6 months for 5 years, then annually

What Are the Treatments Tested in This Trial?

Interventions

• Pertuzumab
• Trastuzumab

Trial Overview The study compares two durations of HER2-targeted therapy: a shorter 6-month course versus the standard 12-month course after surgery. It aims to see if the shorter treatment works just as well for those who responded completely to initial chemo plus trastuzumab.

How Is the Trial Designed?

Group I: Arm 2 (6-month adjuvant therapy) Experimental Treatment 9 Interventions

Patients receive trastuzumab IV or SC on day 1 of each cycle. Patients may also receive pertuzumab IV or SC, at the discretion of the treating investigator, on day 1 of each cycle. Cycles repeat every 21 days for up to 9 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO or MUGA as well as mammography, ultrasound, or MRI throughout the trial. Patients may also optionally undergo blood and tissue sample collection throughout the trial.

Group II: Arm 1 (12-month adjuvant therapy) Active Control 9 Interventions

Patients receive trastuzumab IV or SC on day 1 of each cycle. Patients may also receive pertuzumab IV or SC, at the discretion of the treating investigator, on day 1 of each cycle. Cycles repeat every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO or MUGA as well as mammography, ultrasound, or MRI throughout the trial. Patients may also optionally undergo blood and tissue sample collection throughout the trial.

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials

521

Recruited

224,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+