NCT02219789

Alisertib and Fulvestrant in Treating Patients With Hormone Receptor Positive Breast Cancer That is Metastatic or Locally Advanced and Cannot Be Removed by Surgery

Completed Phase 1 Last updated 3 October 2018

What this trial tests

Phase 1 trial testing Alisertib in Estrogen Receptor Positive in 10 participants. Completed in 1 October 2018.

Timeline

5 December 2014

Primary endpoint
28 March 2016

1 October 2018

Quick facts

Lead sponsor	Mayo Clinic
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	5 December 2014
Primary completion	28 March 2016
Estimated completion	1 October 2018
Sites	1 location across United States

Drugs / interventions tested

• Alisertib — full drug profile →
• Fulvestrant (fulvestrant) — full drug profile →
• Laboratory Biomarker Analysis — full drug profile →

Conditions studied

• Estrogen Receptor Positive — all drugs for Estrogen Receptor Positive →
• Progesterone Receptor Positive — all drugs for Progesterone Receptor Positive →
• Recurrent Breast Carcinoma — all drugs for Recurrent Breast Carcinoma →
• Stage IIIB Breast Cancer — all drugs for Stage IIIB Breast Cancer →

Sponsor

Mayo Clinic

Who can join

18 and older, female only, with Estrogen Receptor Positive or Progesterone Receptor Positive. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial studies the side effects and best dose of alisertib when given together with fulvestrant in treating patients with hormone positive breast cancer that has spread to other parts of the body or has spread from where it started to nearby tissue or lymph nodes and cannot be removed by surgery. Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen and progesterone are type of hormones made by the body and they can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by lowering the amount of estrogen or progesterone the body makes. Giving alisertib together with fulvestrant may be a better treatment for breast cancer.

Publications & conference data

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

1. The two sides of chromosomal instability: drivers and brakes in cancer.
   Hosea R, Hillary S, Naqvi S, Wu S, et al · · 2024 · cited 102× · PMID 38553459 · DOI 10.1038/s41392-024-01767-7
2. Investigational chemotherapy and novel pharmacokinetic mechanisms for the treatment of breast cancer brain metastases.
   Shah N, Mohammad AS, Saralkar P, Sprowls SA, et al · · 2018 · cited 102× · PMID 29604436 · DOI 10.1016/j.phrs.2018.03.021
3. Aurora kinase A in gastrointestinal cancers: time to target.
   Katsha A, Belkhiri A, Goff L, El-Rifai W. · · 2015 · cited 74× · PMID 25987188 · DOI 10.1186/s12943-015-0375-4
4. Scientific Rationale Supporting the Clinical Development Strategy for the Investigational Aurora A Kinase Inhibitor Alisertib in Cancer.
   Niu H, Manfredi M, Ecsedy JA. · · 2015 · cited 46× · PMID 26380220 · DOI 10.3389/fonc.2015.00189
5. Second-Generation Antimitotics in Cancer Clinical Trials.
   Novais P, Silva PMA, Amorim I, Bousbaa H. · · 2021 · cited 37× · PMID 34371703 · DOI 10.3390/pharmaceutics13071011
6. Seize the engine: Emerging cell cycle targets in breast cancer.
   Fuentes-Antrás J, Bedard PL, Cescon DW. · · 2024 · cited 21× · PMID 38264947 · DOI 10.1002/ctm2.1544
7. Mitotic kinases as drivers of the epithelial-to-mesenchymal transition and as therapeutic targets against breast cancers.
   Colón-Marrero S, Jusino S, Rivera-Rivera Y, Saavedra HI. · · 2021 · cited 12× · PMID 33601912 · DOI 10.1177/1535370221991094
8. DNA Repair Genes as Drug Candidates for Early Breast Cancer Onset in Latin America: A Systematic Review.
   Urbina-Jara LK, Martinez-Ledesma E, Rojas-Martinez A, Rodriguez-Recio FR, et al · · 2021 · cited 2× · PMID 34884835 · DOI 10.3390/ijms222313030