Study Details

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The SAPPHO Study: A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer

The purpose of this study is to estimate the probability of participants being off all anti-cancer treatment (with the exception of endocrine therapy for those with ER+ disease) and free of disease progression 4 years from study entry.

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

This study involves questionnaires, medical history and performance status, tumor assessment, pregnancy test (if applicable), blood tests, EKG, ECHO, imaging scans, tumor biopsy, and study drugs.

Incentives

Study Medication

In-person visits:
0-30+

Phone or online visits:
0-30+

Total length of participation:
About 2 years of study treatment and follow up for 4 years after treatment

Looking for Specific Volunteers

Able to participate:

You have been diagnosed with stage 4 breast carcinoma at initial diagnosis
You have been diagnosed with HER2 positive (HER2+) breast cancer

Not eligible if:

You have a prior history of invasive breast carcinoma
You have received systemic therapy for your invasive breast cancer, aside from first-line trastuzumab/pertuzumab/taxane (THP) started prior to enrollment
You have received treatment with any other investigational agents for your breast cancer
You have had any major surgical procedure or significant traumatic injury within 28 days of study entry or an anticipated need for major surgery
You have received extracranial palliative radiation within 7 days prior to starting the study

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Comprehensive Cancer Center
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
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

Claire Dees
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Breast)

IRB Number

25-0742

ClinicalTrials.gov

NCT06439693