Trial · NCT06953882
Impact of Omitting Chemo Based on Patient's Selection for ER-Positive, HER2-Negative Breast Cancer With Ribociclib and Endocrine Therapy
NCT06953882, Phase 2, Recruiting, Yale University
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Impact of Omitting Chemo Based on Patient's Selection for ER-Positive, HER2-Negative Breast Cancer With Ribociclib and Endocrine Therapy. Trials, record NCT06953882. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06953882
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Impact of Omitting Chemo Based on Patient's Selection for ER-Positive, HER2-Negative Breast Cancer With Ribociclib and Endocrine Therapy
- NCT number
- NCT06953882
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 140 participants, estimated
- Lead sponsor
- Yale University
- Conditions
- HER2 Negative Breast Cancer
- Interventions
- Ribociclib 400mg, Letrozole 2.5mg, Anastrazole 1mg, Goserelin 3.6 MG, Adjuvant chemotherapy
- First posted
- 2025-05-01
- Last updated
- 2026-05-26
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Discontinuation rate of ribociclib in patients with resected moderate to high-anatomical risk, low-genomic risk, ER-positive, HER2-negative breast cancer | Within one year of treatment | Discontinuation rate of ribociclib in participants with resected moderate to high-anatomical risk, low-genomic risk (men or premenopausal women T2-3N0 and RS 16-25, or T1-3N1-2 and RS ≤ 25, and postmenopausal women T2-3N0 and RS 26-30, or T1-3N1 and RS 26-30, or T1-3N2 and RS ≤ 25), ER-positive, HER2-negative breast cancer who choose to forgo adjuvant chemotherapy in their treatment regimen. One-year treatment discontinuation is defined as treatment discontinuation within one year for any reason (e.g., adverse events, disease recurrence, patient/investigator decision, lost to follow up, etc). |
| Secondary | Invasive disease-free survival in patients with resected moderate to high-anatomical risk, low-genomic risk, ER-positive, HER2-negative breast cancer | Defined as the time from initiation of treatment to three years post-survival | iDFS is defined as the time from initiation of treatment to the first diagnosis of local invasive recurrence following mastectomy, local invasive recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, contralateral invasive breast cancer, second non-breast primary cancer (excluding squamous or basal cell carcinoma of the skin), or death from any cause prior to recurrence or second primary cancer using STEEP criteria as assessed by investigator. iDFS using STEEP criteria, assessed separately in the participants who select to omit adjuvant chemotherapy (arm 1) and those who include adjuvant chemotherapy in their treatment regimen (arm 2). |
| Secondary | Change from Baseline in Severity of Symptoms in patients with resected moderate to high-anatomical risk, low-genomic risk, ER-positive, HER2-negative breast cancer | At baseline, every three months during the first year and every six months during years 2 and 3 | This seeks to assess the change from baseline in the severity of symptoms. This will be measured using the Functional Assessment of Cancer Therapy-General (FACT-G) GP5. FACT-G GP5 will be scored from scale of 0-4; with 0 indicating "not at all" and 4 indicating "very much". The objective is to describe patient-reported outcomes (PRO) for these measures in participants in arm 1 and arm 2. |
| Secondary | Change from Baseline in Physical Functioning and Global Health Status/Quality of Life in patients with resected moderate to high-anatomical risk, low-genomic risk, ER-positive, HER2-negative breast cancer | At baseline, every three months during the first year and every six months during years 2 and 3 | This seeks to evaluate the change from baseline in the physical functioning sub-scale score and global health status/Quality of Life scale score of participants. This will be measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). This questionnaire is scored from 1 to 4; with 1 indicating 'not at all' and 4 indicating 'very much'. The objective is to describe patient-reported outcomes related to health-related quality-of-life in participants in arm 1 and arm 2. |
| Secondary | Factors Impacting Decision Making in Adjuvant Treatment Decisions in patients with resected moderate to high-anatomical risk, low-genomic risk, ER-positive, HER2-negative breast cancer | At baseline | This seeks to to identify and understand the factors that impact participants' decision-making processes, as assessed by a modified version of the Control Preferences Scale. This tool uses a card-sorting method, where participants are asked to rank five cards with different decision-making roles. It is then scored by the participant's preference order over the five cards. The objective is to explore the factors influencing the decision to include or omit adjuvant treatment among participants in arm 1 and arm 2. This assessment will help in understanding the preferences and considerations of patients regarding their treatment plans. |
| Secondary | Changes in fear of cancer recurrence in patients with resected moderate to high-anatomical risk, low-genomic risk, ER-positive, HER2-negative breast cancer | At baseline, six months, and one year | This seeks to assess the changes in fear of cancer recurrence among participants, measured using the Fear of Cancer Recurrence-7 (FCR-7) scale. The first six items on the scale are scored on a 5-point scale, with 1 indicating "not at all" and 5 indicating "all the time". The seventh item assesses the extent to which Fear of Cancer Recurrence interferes with thoughts and activities on a 10 point scale, where 0 indicates "not at all" and 10 indicates "a great deal". The sale is then totaled; a score of less greater than 4 on items 1-6 or greater than 7 on item 7 suggests a significant level of fear of cancer recurrence. This evaluation aims to provide insights into the emotional and psychological impact of cancer treatment decisions. |
| Secondary | Change from Baseline in Anxiety/Depression in patients with resected moderate to high-anatomical risk, low-genomic risk, ER-positive, HER2-negative breast cancer | At baseline, every three months during the first year and every six months during years 2 and 3 | This seeks to assess the change from baseline in anxiety and depression of participants. This will be measured using the Patient Health Questionnaire-9 (PHQ-9). PHQ-9 will be scored from 0 to 3, with 0 indicating 'not at all' and 3 indicating 'nearly every day'. The scores will then be tallied, with scores ranging from 0-27, where higher scores will indicate greater depression severity. The objective is to describe patient-reported outcomes (PRO) for these measures in participants in arm 1 and arm 2. |
| Secondary | Changes in decision regret in patients with resected moderate to high-anatomical risk, low-genomic risk, ER-positive, HER2-negative breast cancer | At baseline, six months, and one year | This seeks to assess the changes in decision regret among participants, measured using the Decision Regret Scale. This scale is scored from 1 to 5, where 1 indicates "strongly agree" and 5 indicates "strongly disagree". This evaluation aims to provide insights into the emotional and psychological impact of cancer treatment decisions |
| Secondary | Change from Baseline in Severity of Symptoms in patients with resected moderate to high-anatomical risk, low-genomic risk, ER-positive, HER2-negative breast cancer | At baseline, every three months during the first year and every six months during years 2 and 3 | This seeks to assess the change from baseline in the severity of symptoms. This will be measured using the Common Terminology Criteria for Adverse Events-Patient Reported Outcome (CTCAE-PRO). CTCAE-PRO will be scored from "none/not at all" to "very severe/severe". The objective is to describe patient-reported outcomes (PRO) for these measures in participants in arm 1 and arm 2. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06953882
GET https://conductscience.org/api/trials/v1/NCT06953882/registered