Converting HR+ Breast Cancer Into an Individualized Vaccine

Conditions

• Breast Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• Focal Radiation therapy — RADIATION
  Focal hypo-fractionated radiation therapy 8 Gy x 3 fractions, starting day 8, every other day (M/W/F or W/F/M or F/M/W).
• Pembrolizumab (200mg IV for 30 minutes — DRUG
  Pembrolizumab, on day 12 (last day of radiotherapy), infused over 200mg IV over 30 minutes and then repeated every 3 weeks until disease progression or unacceptable toxicity.
• CDX-301 — BIOLOGICAL
  Ftl-3 ligand, self-administered by subcutaneous injections at week 1, daily, for 5 consecutive days.

Study Details

Newly diagnosed post-menopausal women with clinical stage II-III, HR+HER2- breast cancer are eligible to a randomized trial, concurrently open at five US academic institutions. Patients receiving 4 months of standard neoadjuvant hormonal therapy with letrozole are randomly assigned to one of 4 arms of a trial testing focal hypo-fractionated RT alone or with immunotherapy combinations.

Key Dates

Start date

Mar 17, 2020

Status verified

Jan 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2027

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: ARM 1
  Focal hypo-fractionated radiation therapy 8 Gy x 3 fractions, starting day 8, every other day (M/W/F or W/F/M or F/M/W).
• Active Comparator: ARM 2
  Focal hypo-fractionated radiation therapy - 8 Gy x 3 fractions starting day 8, every other day (M/W/F or W/F/M or F/M/W). + Pembrolizumab, on day 12 (last day of radiotherapy), infused over 200mg IV over 30 minutes and then repeated every 3 weeks until disease progression or unacceptable toxicity.
• Active Comparator: ARM 3
  Ftl-3 ligand, self-administered by subcutaneous injections at week 1, daily, for 5 consecutive days + Focal hypo-fractionated radiation therapy - 8 Gy x 3 fractions starting day 8, (every other day (M/W/F or W/F/M or F/M/W).
• Active Comparator: ARM 4
  Ftl-3 ligand, self administered subcutaneous injections at day 1 for 5 consecutive days+ Focal hypo-fractionated Radiation therapy starting day 8, - 8 Gy x 3 fractions, every other day (M/W/F or W/F/M or F/M/W). + Pembrolizumab, on day 12 (last day of radiotherapy), 200mg IV infused over 30 minutes then repeated every 3 weeks until disease progression or unacceptable toxicity.

Primary Outcome Measure

Tolerability will be demonstrated if no grade 3 or higher toxicities are observed in the first 8 patients, of each arm. [ Time Frame: 3 years ]

Central Contacts

• Fabiana Gregucci, M.D.
  646 962-3110
  [email protected]

Locations (8)

Find similar trials in Los Angeles, CA

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