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NCT07067138 · ClinicalTrials.gov registry record · NA

A Synthetic Lethality-Focused Algorithm to Identify Therapeutic Options in Advanced Metastatic Breast Cancer (SYNTHESIS-Breast)

A NA study of Breast Cancer and Breast Carcinoma, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
NA
Development phase
175
Enrollment target
1
Study location

NCT07067138: Recruiting NA study of Breast Cancer and Breast Carcinoma, sponsored by National Cancer Institute (NCI).

NCT07067138 is a NA study of Breast Cancer and Breast Carcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 175 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (94% 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

NCT07067138, a NA study of Breast Cancer and Breast Carcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
NA
Development phase
175 participants
Enrollment target
1
Study location

Study Summary

Background: Breast cancer is the most common cancer in US women. There are different types of breast cancers; some are aggressive and difficult to treat. Researchers want to know if an algorithm (ENLIGHT) can help choose approved drugs that will treat these cancers more effectively. Objective: To test whether ENLIGHT can find better treatments for aggressive breast cancers. Eligibility: People aged 18 years and older with triple-negative or endocrine therapy resistant breast cancer; the cancer must have either failed to respond to treatment or come back after treatment. Design: Participants will be screened. A sample of tissue taken from the tumor will be tested using ENLIGHT as well as another method (TruSight Oncology 500). Participants will be assigned to 1 of 3 groups based on the algorithm search results: Group 1: No drug option was recommended. Participants will continue with their standard treatment with their local doctors. Group 2: A drug already approved for the participant's disease was recommended, but the participant has not yet received it. These results will be sent to the participant's local doctors. Participants may return to the NIH if their disease gets worse after using the suggested drugs. Group 3: A drug approved for other uses was recommended. Participants will be treated with the recommended drugs at the NIH; their care will be managed by an NIH doctor. They will continue to receive treatment as long as the drugs are helping them. They will have follow-up visits for 2 years after treatment ends. Participants who are not treated at the NIH will be contacted for a check on their health every 3 months for 2 years.

Primary Outcome

The number of participants of the first 20 enrolled overall having a match via ENLIGHT and being assigned to Arm 3.

Interventions

  • DEVICE Expression Networks for highLIGHting Tumor vulnerabilities (ENLIGHT)
  • DEVICE TruSight(R) Oncology 500
  • DEVICE TruSeq Matched Tumor Normal Whole Exome Sequencing Assay

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 175 participants
Start Date 2026-02-23
Est. Completion 2029-08-04
Phase NA
National Cancer Institute (NCI)

3,257 total trials

What NCT07067138 shows while recruiting

NCT07067138 is an interventional study that assigns participants to a tested intervention. The registered 175 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 (94% lower).

The record links to 4 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Expression Networks for highLIGHting Tumor vulnerabilities (ENLIGHT) is the first listed.

NCT07067138 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT07067138 about?

NCT07067138 is a clinical study titled "A Synthetic Lethality-Focused Algorithm to Identify Therapeutic Options in Advanced Metastatic Breast Cancer (SYNTHESIS-Breast)". Background: Breast cancer is the most common cancer in US women. There are different types of breast cancers; some are aggressive and difficult to treat. Researchers want to know if an algorithm (ENLIGHT) can help choose approved drugs that will treat these cancers more effectively. Objective: To...

What is the current status of trial NCT07067138?

This trial is currently recruiting. It is a NA study. The enrollment target is 175 participants. The study started on 2026-02-23. Estimated completion is 2029-08-04.

What conditions does trial NCT07067138 study?

This clinical trial studies the following conditions: Breast Cancer, Breast Carcinoma, Cancer of the Breast, Malignant Neoplasm of Breast.

What interventions are being tested in trial NCT07067138?

The interventions under investigation include: Expression Networks for highLIGHting Tumor vulnerabilities (ENLIGHT) (DEVICE), TruSight(R) Oncology 500 (DEVICE), TruSeq Matched Tumor Normal Whole Exome Sequencing Assay (DEVICE).

Who is sponsoring clinical trial NCT07067138?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07067138 being conducted?

This trial has 1 study location across Maryland. 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 NCT07067138's enrollment target sits among peer trials

175 416th of 1224 higher than 808 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 NCT07067138, the US trial registry maintained by the National Library of Medicine. NCT07067138 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.