NCT04139993

RBX7455 Before Surgery for the Treatment of Operable Breast Cancer

Terminated Phase 1 Last updated 4 October 2023

What this trial tests

Phase 1 trial testing Microbiota-based Formulation RBX7455 in Anatomic Stage I Breast Cancer AJCC v8 in 3 participants. Terminated before completion.

Timeline

31 August 2020

Primary endpoint
11 January 2023

11 January 2023

Quick facts

Lead sponsor	Mayo Clinic
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	31 August 2020
Primary completion	11 January 2023
Estimated completion	11 January 2023
Sites	1 location across United States

Drugs / interventions tested

• Microbiota-based Formulation RBX7455 — full drug profile →

Conditions studied

• Anatomic Stage I Breast Cancer AJCC v8 — all drugs for Anatomic Stage I Breast Cancer AJCC v8 →
• Anatomic Stage IA Breast Cancer AJCC v8 — all drugs for Anatomic Stage IA Breast Cancer AJCC v8 →
• Anatomic Stage IB Breast Cancer AJCC v8 — all drugs for Anatomic Stage IB Breast Cancer AJCC v8 →
• Anatomic Stage II Breast Cancer AJCC v8 — all drugs for Anatomic Stage II Breast Cancer AJCC v8 →

Sponsor

Mayo Clinic

Who can join

18 and older, female only, with Anatomic Stage I Breast Cancer AJCC v8 or Anatomic Stage IA Breast Cancer AJCC v8. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This clinical trial studies the side effects and possible benefits of RBX7455 given before surgery in treating patients with breast cancer that can be removed by surgery (operable). RBX7455 contains live intestinal microbes (active drug), which are obtained from healthy human stool and may restore the normal balance of microorganisms in the intestines through the transplant of live and beneficial microorganisms.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cell therapies in the clinic.
   Wang LL, Janes ME, Kumbhojkar N, Kapate N, et al · · 2021 · cited 99× · PMID 34027097 · DOI 10.1002/btm2.10214
2. Gut microbiota-mediated immunomodulation in tumor.
   Liu X, Chen Y, Zhang S, Dong L. · · 2021 · cited 76× · PMID 34217349 · DOI 10.1186/s13046-021-01983-x
3. Gut Microbiota and Breast Cancer: The Dual Role of Microbes.
   Álvarez-Mercado AI, Del Valle Cano A, Fernández MF, Fontana L. · · 2023 · cited 50× · PMID 36672391 · DOI 10.3390/cancers15020443
4. Trial watch : the gut microbiota as a tool to boost the clinical efficacy of anticancer immunotherapy.
   Daillère R, Derosa L, Bonvalet M, Segata N, et al · · 2020 · cited 29× · PMID 32934879 · DOI 10.1080/2162402x.2020.1774298
5. The Link Between the Microbiota and HER2+ Breast Cancer: The New Challenge of Precision Medicine.
   Di Modica M, Arlotta V, Sfondrini L, Tagliabue E, et al · · 2022 · cited 19× · PMID 35912227 · DOI 10.3389/fonc.2022.947188
6. The Urgent Threat of <i>Clostridioides difficile</i> Infection: A Glimpse of the Drugs of the Future, with Related Patents and Prospects.
   Alshrari AS, Hudu SA, Elmigdadi F, Imran M. · · 2023 · cited 17× · PMID 36830964 · DOI 10.3390/biomedicines11020426
7. The Present and Future of Clinical Management in Metastatic Breast Cancer.
   Lin PH, Laliotis G. · · 2022 · cited 14× · PMID 36233758 · DOI 10.3390/jcm11195891
8. Commensal Microbiota and Cancer Immunotherapy: Harnessing Commensal Bacteria for Cancer Therapy.
   Bae J, Park K, Kim YM. · · 2022 · cited 14× · PMID 35291651 · DOI 10.4110/in.2022.22.e3