Return to results

Breast Cancer

S1703: Randomized Non-Inferiority Trial Comparing Overall Survival of Patients Monitored with Serum Tumor Marker Directed Disease Monitoring (STMDDM) versus Usual Care in Patients with Metastatic Hormone Receptor Positive HER-2 Negative Breast Cancer

Description

This is a randomized non-inferiority trial comparing overall survival of patients monitored with serum tumor marker directed disease monitoring (STMDDM) versus usual care in patients with metastatic hormone receptor positive breast cancer.

Inclusion Notes

For a full description of this trial, please go to the listing on www.clinicaltrials.gov

For Medical Personnel

Disease Related Criteria

  1. Patients must have a diagnosis of hormone receptor positive (ER+ and/or PR+), HER-2 negative, metastatic (M1) breast cancer and must be receiving or plan to receive first-line systemic treatment for metastatic disease.

NOTE: Participants are eligible if they have either de-novo metastatic breast cancer and/or recurrent breast cancer from an earlier stage that is now metastatic.

  1. Patients must be registered to Step 1 between 14 days prior to

and 28 days after start of first-line systemic treatment for metastatic disease.


Clinical/Laboratory Criteria

  1. Patients (women and men) must be ≥ 18 years of age
  2.  Patients must have been tested for all of the following breast cancer specific STMs after diagnosis of metastatic disease and within ±14 days of initiation of first-line systemic treatment for metastatic disease:

• CA 15-3

• CA 27.29

• CEA

At least one of these STMs must have been ≥ 2 x the institutional upper limit of normal at this time

  1. Patients must have systemic radiographic imaging prior to initiation of systemic therapy for treatment of metastatic breast cancer and prior to Step 1 registration with either:

• a computed tomography (CT) scan of the chest and abdomen with or without CT pelvis, and with or without bone scan

or

• a positron emission tomography (PET) scan with or without CT

note: the treating physician can order additional imaging tests at any point prior to randomization at their discretion.

  1. Patients must be willing to obtain disease monitoring (imaging

and/or serum tumor markers) at their current center for the duration of the study intervention (312 weeks after Step 2 randomization).

  1. Patients with known cirrhosis, untreated B12 deficiency,

thalassemia, or sickle cell anemia are not eligible as these could cause falsely elevated STM levels.

  1. Patients with known brain metastases are not eligible as they

may require regular radiographic monitoring to assess

treatment response.

  1. Patients must not be currently enrolled or plan to participate in

a first-line treatment trial for metastatic breast cancer with a defined monitoring schedule.

  1. Patients who are able to complete questionnaires in English or

Spanish must participate in patient-reported outcome (PRO) assessments as outlined in Section 14.4.

  1. Patients must not be pregnant due to the potential harm to the

fetus from radiation exposure from radiographic imaging.

Except for breast cancer (and previous history of breast cancer), no other prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease free for five years.

Start Date

Monday, December 17, 2018

Principal / Contact Name

John A. Pablo, MD

Phone

912-819-5704