You have matched to 1 trial

Guest Profile:  No profile selected

Copy link
Sort by zip code: 94107 Hide Map Icon
NCT06247995
Clear All Filters
mail-icon

Register to sign up for Trial Alerts

Receive emails about new trials that match your profile.
1

Radioactive Drug with Chemotherapy for Metastatic ER+, HER2- or HER2 Low, GRPR+ Breast Cancer

A Phase I/II, Open-label, Multi-center Trial of [177Lu]Lu-NeoB in Combination With Capecitabine in Adult Patients With Gastrin Releasing Peptide Receptor Positive, Estrogen Receptor-positive, Human Epidermal Growth Factor Receptor-2 Negative Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inh...(NeoB-Cap1)

Purpose: To study the safety, best dose, and effects (good and bad) of 177Lu-Lu-NeoB, an experimental radioactive drug, with capecitabine (Cytoxan®) chemotherapy.

Who is this for?: People with metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) or HER2 low breast cancer that is GRPR positive (GRPR+) who have received no more than 3 lines of hormone therapy (including a CDK4/6 inhibitor) for metastatic disease. You must not have received more than 1 line of chemotherapy or antibody drug conjugate (ADC) for metastatic disease. View full eligibility criteria

What's involved?

You will receive the following:

  • 177Lu-Lu-NeoB, by IV, every 3-6 weeks
  • Capecitabine (Cytoxan®), by mouth, daily, 2 weeks on, 1 week off
  • PET/CT or PET/MRI scan with 68Ga-Ga-NeoB, by IV, 1-2 times

What's being studied?

  • Researchers are developing a new class of drugs called radiopharmaceuticals, which deliver radiation therapy directly and specifically to cancer cells.
  • 177Lu-Lu-NeoB is an experimental radiation therapy drug called a radiopharmaceutical or radioactive drug.
  • 177Lu-Lu-NeoB targets tumors that are positive for GRPR (gastrin releasing peptide receptor).
  • Capecitabine (Cytoxan®) is an FDA-approved chemotherapy drug.
  • In this trial, HER2 low is defined as IHC 1+ or IHC 2+/ISH-.
  • A positron emission tomography (PET) scan is an imaging test that uses a radioactive substance called a tracer that can look for and attach to cancer cells.
  • The experimental tracer in this study is 68Ga-Ga-NeoB.
  • A computed tomography (CT) scan produces body pictures created by x-ray energy.
  • A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.

How can I learn more?

1

Radioactive Drug with Chemotherapy for Metastatic ER+, HER2- or HER2 Low, GRPR+ Breast Cancer

A Phase I/II, Open-label, Multi-center Trial of [177Lu]Lu-NeoB in Combination With Capecitabine in Adult Patients With Gastrin Releasing Peptide Receptor Positive, Estrogen Receptor-positive, Human Epidermal Growth Factor Receptor-2 Negative Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inh...(NeoB-Cap1)
Icon

Nearest Location:
381 miles
Hoag Memorial Hospital Presbyterian
Newport Beach, CA

Icon

Visits:
1 visit every 3 weeks for 9 months, then every 1.5 months

Icon

ClinicalTrials.gov: NCT06247995

Icon

Phase I-II

HELP GUIDE
HELP GUIDE
BESbswy