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NCT07222215 · ClinicalTrials.gov registry record · Phase 2

PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA)

A Phase 2 study of Breast Cancer and Metastatic Breast Cancer, sponsored by Kristina A. Fanucci.

Recruiting
Registry status
Phase 2
Development phase
297
Enrollment target
1
Study location

NCT07222215: Recruiting Phase 2 study of Breast Cancer and Metastatic Breast Cancer, sponsored by Kristina A. Fanucci.

NCT07222215 is a Phase 2 study of Breast Cancer and Metastatic Breast Cancer that is actively recruiting participants, run by Kristina A. Fanucci. The registered enrollment target is 297 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07222215, a Phase 2 study of Breast Cancer and Metastatic Breast Cancer, is actively recruiting participants, sponsored by Kristina A. Fanucci.

RECRUITING
Registry status
Phase 2
Development phase
297 participants
Enrollment target
1
Study location

Study Summary

The goal of this research study is to compare a combination of two drugs, capecitabine and elacestrant to capecitabine alone as a treatment for advanced estrogen receptor-positive (ER+) breast cancer. This study is designed for participants with cancer that has previously stopped responding to medication in the class of therapy called CDK 4/6 inhibitors, including palbociclib, ribociclib, or abemaciclb. The names of the study drugs involved in this study are: * Elacestrant (a type of selective estrogen receptor degrader) * Capecitabine (a type of fluoropyrimidine antimetabolite)

Primary Outcome

PFS based on the Kaplan-Meier method is defined as the time from study randomization to disease progression per RECIST 1.1 or death. Patients alive without disease progression are censored at the date of last disease evaluation.

Interventions

  • DRUG Capecitabine
  • DRUG Elacestrant

Study Locations (1)

Massachusetts

  • Dana-Farber Cancer Institute - Boston

Trial Details

FieldValue
Enrollment Target 297 participants
Start Date 2026-01-16
Est. Completion 2030-10-01
Phase Phase 2
Kristina A. Fanucci

2 total trials

What NCT07222215 shows while recruiting

NCT07222215 is an interventional study that assigns participants to a tested intervention. The registered 297 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (89% lower).

The record links to 9 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Capecitabine is the first listed.

NCT07222215 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT07222215 about?

NCT07222215 is a clinical study titled "PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA)". The goal of this research study is to compare a combination of two drugs, capecitabine and elacestrant to capecitabine alone as a treatment for advanced estrogen receptor-positive (ER+) breast cancer. This study is designed for participants with cancer that has previously stopped responding to medic...

What is the current status of trial NCT07222215?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 297 participants. The study started on 2026-01-16. Estimated completion is 2030-10-01.

What conditions does trial NCT07222215 study?

This clinical trial studies the following conditions: Breast Cancer, Metastatic Breast Cancer, Breast Neoplasms, Hormone Receptor-Positive Breast Cancer, Estrogen Receptor-positive Breast Cancer.

What interventions are being tested in trial NCT07222215?

The interventions under investigation include: Capecitabine (DRUG), Elacestrant (DRUG).

Who is sponsoring clinical trial NCT07222215?

This trial is sponsored by Kristina A. Fanucci, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07222215 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07222215's enrollment target sits among peer trials

297 290th of 1224 higher than 935 of 1,224 other Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07222215, the US trial registry maintained by the National Library of Medicine. NCT07222215 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.