Active Surveillance in Older Women With ER+ Breast Cancer
Protocol-Directed Active Surveillance for Older Women With Small, Screen-Detected, ER+/HER2- Breast Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 70 Years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether watching small breast cancers with repeated imaging tests, instead of treating them, is safe. It is for women age 70 or older with stage I breast cancer that is ER-positive and HER2-negative. Researchers will track how many cancers grow or spread within 12 months.
ACTIVE is a prospective, single-arm, phase I/IIa study examining an active surveillance strategy for small, screen-detected, luminal breast cancer. Patients aged 70 or older with clinical stage I ER+/HER2- breast cancer are eligible. The goal of this clinical trial is to learn if an active surveillance strategy (serial imaging rather than therapeutic intervention) is a safe approach to monitor small breast cancers. The main question to answer is the proportion of participants who experience tumor progression by 12 months.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Women age 70 or older with invasive breast cancer, meaning cancer that has grown into nearby breast tissue.
- No surgery to remove the tumor or underarm lymph nodes, and no cancer medicines or radiation for this cancer. Cancer found after a biopsy that removed unusual breast tissue may qualify.
- Cancer was found on a screening mammogram.
- Tumor is 2 centimeters or smaller on ultrasound, or on a mammogram if ultrasound cannot show it. Exams and scans show no cancer in lymph nodes.
- Tumors 1 centimeter or smaller must be grade I or II. Tumors larger than 1 centimeter, up to 2 centimeters, must be grade I. Grade describes how abnormal cancer cells look.
- Cancer must be ER-positive, with at least 60% of cells having estrogen receptors, and HER2-negative, meaning it does not have high levels of the HER2 protein.
- People with memory or thinking problems may join if a legal representative can give consent.
- A stored tissue sample must be available before joining and submitted for the study.
Who can't join
- Any prior treatment for this cancer, such as hormone-blocking medicine, chemotherapy, radiation, or an experimental treatment.
- Current breast cancer judged by the study doctor to be cancer that has returned.
- Cancer in more than one spot in the breast.
- Past DCIS in the opposite breast, meaning abnormal cells inside milk ducts, or LCIS in either breast, meaning abnormal cells in milk-making glands. Past radiation to the breast with the current cancer also rules out joining.
- Inflammatory breast cancer, a type that affects the skin of the breast.
- Male breast cancer.
- A severe, uncontrolled health problem that the doctor believes makes the study unsafe or hard to follow. Examples include serious digestive problems that affect how medicines are absorbed, or severe liver problems.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Women aged 70 years or older with a diagnosis of invasive breast cancer who have not undergone surgical resection of the primary invasive tumor and/or axillary lymph nodes, have not undertaken any systemic therapy, and have not received radiation therapy as a treatment for this diagnosis. Patients with invasive cancer that is identified after excisional biopsy for atypia are included. * Tumors must have been identified through mammographic screening. * Tumor is less than or equal to 2cm (T1a through T1c) in maximum dimension based on diagnostic ultrasound, or if not visible on ultrasound, then on mammogram. Must have clinically and radiographically node negative disease. Inclusion criteria for different tumor sizes is as follows: * cT1a or cT1b (≤ 1cm): Nottingham Grade I or II allowed entry. * cT1c (\>1-2cm): only Nottingham Grade I allowed entry. * Breast cancer must be ER positive and HER2 negative according to the definition below, as assessed by local pathology. * ER is considered positive if there are ≥ 60% positive tumor nuclei in the samples. * HER2 negativity is defined per the current ASCO/CAP Clinical Practice Guideline. * Patients with cognitive impairment are eligible provided that a legal surrogate is able to sign informed consent for study participation. * Archival tissue will be submitted for all participants. Tissue must be confirmed available prior to registration. Exclusion Criteria: * Prior anti-cancer therapy (e.g., endocrine therapy, chemotherapy, radiation therapy, or investigational therapy) for the current breast cancer diagnosis. * Current breast cancer diagnosis that is deemed a recurrence, at the discretion of the treating investigator. * Multifocal or multicentric disease. * Patients with a history of contralateral DCIS, or ipsilateral or contralateral LCIS are not eligible. Patients with a history of any ipsilateral breast radiation are not eligible. * Diagnosis of inflammatory breast cancer (T4d). * Male breast cancer. * Any concurrent severe and uncontrolled medical condition that, in the treating clinician's opinion, would pose unacceptable safety risks or compromise compliance with the protocol. Such conditions could include: impairment of gastrointestinal tract function or gastrointestinal disease that may significantly alter the absorption of oral medications (uncontrolled Crohn disease or ulcerative colitis, uncontrolled chronic nausea, vomiting diarrhea, malabsorption, or small bowel resection); severe liver impairment (Child-Pugh Class C).
Study sites (1)
PA
- University of Pittsburgh Medical Center · Pittsburgh, PA 15213Neil Carleton, MD, PhD · Study contact · 412-266-1991 · carletonn2@upmc.eduMore trials in Pittsburgh