• Home
  • Study Details
Open

ShortStop-HER2: Shortened Duration of Adjuvant Therapy in Patients with Early-Stage HER2+ Breast Cancer Who Achieve pCR After Neoadjuvant Chemotherapy with HER2 Blockade

The purpose of this study is to compare the effectiveness of 6 months of HER2-targeted medications (trastuzumab with or without pertuzumab) versus 12 months of HER2-targeted medications at reducing the risk of breast cancer coming back or death in patients with early-stage HER2+ breast cancer who had a pCR after preoperative chemotherapy combined with trastuzumab. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study approach prevents your cancer from coming back compared to the usual approach. Post-surgery trastuzumab with or without pertuzumab is already approved by the FDA for use in early-stage HER2+ breast cancer. There will be about 1524 people taking part in this study.

Age & Gender

  • 18 years ~ 99 years
  • Male, Female, Gender Inclusive

Visit Availability

  • Standard business hours (M-F, 8-5)

Location

United States (Nationwide)

What will be asked of you

When you join this study, your doctor will first review your health information to ensure your safety. Throughout the study, you will have regular exams and tests to monitor your health. While most of these are standard care, some are for research purposes only, such as completing two forms. If you speak English or Spanish, you will fill out a form called PROCTCAE about side effects you experience, which helps researchers understand how cancer and its treatment affect people. You will also complete a form about any extra costs you incur during treatment. Since these forms are for research, your answers will not be shared with your study doctor; you should speak directly with your doctor or nurse about any serious health concerns. Your responsibilities as a participant include: keeping all study appointments; reporting all medications, supplements, and any side effects; and informing your doctor of any outside medical visits, hospital stays, or participation in other studies. Finally, you must not become pregnant, breastfeed, or father a child while in the study. You must also inform your study doctor immediately if you or your partner become pregnant during the study or within seven months after your last dose of trastuzumab or pertuzumab.

In-person visits:
All labs, physical exams, treatment, and imaging visits will be in person.
Total length of participation:
6-12 months of treatment 10 years of follow-up

Looking for Specific Volunteers

Able to participate:

  • You are diagnosed with clinical stage T1c-T3 (or Tx) and nodal stage No-N1 (except T3N1 tumors)
  • You have received neoadjuvant chemotherapy in combination with trastuzumab with or without pertuzumab for a minimum of 12 weeks. All chemotherapy must have been completed
  • You have no residual invasive disease in the breast or lymph nodes after the completion of neoadjuvant therapy
  • You have HER2+ disease

Not eligible if:

  • You have stage IV (metastatic) breast cancer
  • You have a history of prior invasive breast cancer
  • You are pregnant or nursing

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Secondary Visit Location

UNC Hospitals Hillsborough Campus
460 Waterstone Dr, Hillsborough, NC 27278, USA

Additional Study Information

Principal Investigator

Jeffrey Aldrich
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Breast)

IRB Number

25-2392

ClinicalTrials.gov

NCT06876714

Research for Me logo

Copyright © 2013-2022 The NC TraCS Institute, the integrated home of the NIH Clinical and Translational Science Awards (CTSA) Program at UNC-CH.  This website is made possible by CTSA Grant UL1TR002489 and the National Center for Advancing Translational Sciences.

Questions?

  • This email address is being protected from spambots. You need JavaScript enabled to view it.
logo for the North Carolina Translational and Clinical Sciences Institute
logo for UNC Health
logo for UNC School of Medicine
logo for UNC Research