Trial · NCT01272037
Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer
NCT01272037, Phase 3, Active not recruiting, National Cancer Institute (NCI); results first posted 2023-06-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer. Trials, record NCT01272037. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01272037
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer
- NCT number
- NCT01272037
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 5,018 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma, Multicentric Breast Carcinoma, Multifocal Breast Carcinoma, Synchronous Bilateral Breast Carcinoma
- Interventions
- Anastrozole, Exemestane, Laboratory Biomarker Analysis, Letrozole, Quality-of-Life Assessment, Systemic Chemotherapy, Tamoxifen Citrate
- First posted
- 2011-01-07
- Last updated
- 2026-10-26
- Results first posted
- 2023-06-27
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Invasive Disease-Free Survival (IDFS) | 5 years after randomization | From date of randomization (2nd Registration) to date of first invasive recurrence (local, regional or distant), second invasive primary cancer (breast or not), or death due to any cause. Patients last known to be alive who have not experienced recurrence or second primary cancer are censored at their last contact date. This is the STEEP definition of invasive disease-free survival. Kaplan-Meier estimates were calculated for the 5-year IDFS rate. Due to the results of the third prespecified interim analysis, prespecified separate analyses were conducted for all outcomes by menopausal status (see Statistical Analysis 2). The NCI and data and safety monitoring committee recommended early reporting of the data. After the primary analysis, changes in eligibility status were identified for three participants, making the population of eligible and evaluable participants different between the reporting of this outcome and both the Participant Flow section and the Adverse Events section. |
| Secondary | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Duration of treatment and follow-up until death or 3 years after randomization | Only adverse events that are possibly, probably, or definitely related to study drug are reported. Assessed at 6, 12, 24, and 36 months after randomization. |
| Secondary | Overall Survival (OS) | 5.5 years after randomization | Time from date of randomization (2nd Registration) to date of death due to any cause. Participants last known to be alive are censored at their last contact date. |
| Secondary | Distant Disease-Free Survival (DDFS) | 5.5 years after randomization | Time from date of randomization (2nd Registration) to date of invasive distant disease recurrence, second invasive primary cancer (breast or not) or death due to any cause. Participants last known to be alive who have not experienced distant recurrence, or second primary cancer are censored at their last contact date. This secondary outcome requires continuing to follow the patient after local recurrence in order to ascertain subsequent distant recurrence. Invasive recurrence is defined as: appearance of any new invasive lesion(s) during or after protocol treatment. Whenever possible, recurrences should be documented histologically. Invasive recurrence includes local, regional, or distant recurrence with an invasive component. A new diagnosis of ipsilateral or contralateral DCIS without an invasive component is not considered to be a recurrence. |
| Secondary | Local Disease-Free Interval (LDFI) | From date of randomization to a maximum of 5.5 years or death | Time from date of randomization (2nd Registration) to date of invasive local or regional recurrence. Participants last known to be alive without recurrence are censored at their last contact date. Participants with distant recurrence, second primary cancer or death are censored at the time of that event. Invasive recurrence is defined as: appearance of any new invasive lesion(s) during or after protocol treatment. Whenever possible, recurrences should be documented histologically. Invasive recurrence includes local, regional, or distant recurrence with an invasive component. A new diagnosis of ipsilateral or contralateral DCIS without an invasive component is not considered to be a recurrence. |
| Secondary | Participant-Reported Anxiety | 6 months after randomization | Anxiety is evaluated with the Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety Short Form. Raw PROMIS scores can be re-scaled into T-scores based on a reference population with a mean score of 50 and a standard deviation of 10. Higher scores reflect greater anxiety. PROMIS Anxiety scores at the 6 month timepoint will be compared between the two randomized study arms separately by menopausal status. |
| Secondary | Participant-Reported Health Status | 6 months after randomization | Assessed using the EuroQol-5D (EQ-5D), in which participants rate their health status in five different health-related domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The raw scores can be converted to index scores on a scale of 0 to 1, where a higher index score represents better health. EQ-5D index scores at the 6-month timepoint will be compared between the two randomized study arms separately by menopausal status. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Invasive Disease-Free Survival (IDFS) | 5 years after randomization | For the participants flow and baseline characteristics summary, 5018 eligible participants were included. However, among them, there were 34 participants (10 in the chemo and endocrine arm, and 24 in the endocrine alone arm) that withdrew consent immediately after randomization; thus these participants were excluded from the survival analyses. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Duration of treatment and follow-up until death or 3 years after randomization | Eligible participants who received at least one dose of protocol treatment and assessed for Adverse Event. | Participants | NUMBER |
| SECONDARY | Overall Survival (OS) | 5.5 years after randomization | |||
| SECONDARY | Distant Disease-Free Survival (DDFS) | 5.5 years after randomization | |||
| SECONDARY | Local Disease-Free Interval (LDFI) | From date of randomization to a maximum of 5.5 years or death | |||
| SECONDARY | Participant-Reported Anxiety | 6 months after randomization | |||
| SECONDARY | Participant-Reported Health Status | 6 months after randomization | |||
| POST_HOC | Distant Relapse-Free Survival (DRFS) | 5 years after randomization | Eligible and evaluable participants | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group286
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Invasive Disease-Free Survival (IDFS) | Chemo and Endocrine Therapy | Premenopausal | 93.9 | percentage of participants | |
| Invasive Disease-Free Survival (IDFS) | Endocrine Therapy Alone | Premenopausal | 89.0 | percentage of participants | |
| Invasive Disease-Free Survival (IDFS) | Chemo and Endocrine Therapy | Postmenopausal | 91.3 | percentage of participants | |
| Invasive Disease-Free Survival (IDFS) | Endocrine Therapy Alone | Postmenopausal | 91.9 | percentage of participants | |
| Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Chemo and Endocrine Therapy | Abdominal infection | 1 | Participants | |
| Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Endocrine Therapy Alone | Abdominal infection | 0 | Participants | |
| Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Chemo and Endocrine Therapy | Abdominal pain | 7 | Participants | |
| Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Endocrine Therapy Alone | Abdominal pain | 0 | Participants | |
| Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Chemo and Endocrine Therapy | Acute kidney injury | 1 | Participants | |
| Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs | Endocrine Therapy Alone | Acute kidney injury | 0 | Participants |
1 to 10 of 286Source ClinicalTrials.gov
See all 286 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chemo and Endocrine Therapy | 2,511 | |
| Overall Study | STARTED | Endocrine Therapy Alone | 2,507 | |
| Overall Study | COMPLETED | Chemo and Endocrine Therapy | 1,504 | |
| Overall Study | COMPLETED | Endocrine Therapy Alone | 1,547 | |
| Overall Study | NOT COMPLETED | Chemo and Endocrine Therapy | 1,007 | |
| Overall Study | NOT COMPLETED | Endocrine Therapy Alone | 960 |
Source ClinicalTrials.gov
Adverse events32
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neutrophil count decreased | Investigations | Chemo and Endocrine Therapy | 151 | 2,062 | |
| other | Neutrophil count decreased | Investigations | Endocrine Therapy Alone | 2 | 2,342 | |
| serious | Anemia | Blood and lymphatic system disorders | Chemo and Endocrine Therapy | 1 | 2,062 | |
| serious | Anemia | Blood and lymphatic system disorders | Endocrine Therapy Alone | 0 | 2,342 | |
| serious | Cardiac arrest | Cardiac disorders | Chemo and Endocrine Therapy | 2 | 2,062 | |
| serious | Cardiac arrest | Cardiac disorders | Endocrine Therapy Alone | 2 | 2,342 | |
| serious | Gastrointestinal disorders-Other | Gastrointestinal disorders | Chemo and Endocrine Therapy | 1 | 2,062 | |
| serious | Gastrointestinal disorders-Other | Gastrointestinal disorders | Endocrine Therapy Alone | 0 | 2,342 | |
| serious | Typhlitis | Gastrointestinal disorders | Chemo and Endocrine Therapy | 1 | 2,062 | |
| serious | Typhlitis | Gastrointestinal disorders | Endocrine Therapy Alone | 0 | 2,342 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chemo and Endocrine Therapy | 161 | 2,487 |
| Total, all-cause mortality | Endocrine Therapy Alone | 175 | 2,497 |
| Total, other adverse events | Chemo and Endocrine Therapy | 151 | 2,062 |
| Total, other adverse events | Endocrine Therapy Alone | 2 | 2,342 |
| Total, serious adverse events | Chemo and Endocrine Therapy | 14 | 2,062 |
| Total, serious adverse events | Endocrine Therapy Alone | 9 | 2,342 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants3
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10CA180888 | SWOG Network Group Operations Center of the NCTN | LARA, PRIMO N.; HERSHMAN, DAWN | UNIVERSITY OF CALIFORNIA AT DAVIS | NATIONAL CANCER INSTITUTE | 2014 to 2026 | NIH RePORTER |
| U10CA180830 | NCI NCTN- Network Lead Academic Participating Site: USC | LENZ, HEINZ JOSEF; EL-KHOUEIRY, ANTHONY BOUTROS; QUINN, DAVID IAN | UNIVERSITY OF SOUTHERN CALIFORNIA | NATIONAL CANCER INSTITUTE | 2014 to 2018 | NIH RePORTER |
| U10CA032102 | Southwest Oncology Group Treatment Grant | BLANKE, CHARLES D. | OREGON HEALTH & SCIENCE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2013 | NIH RePORTER |
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Chemo and Endocrine Therapy vs Endocrine Therapy Alone: deaths from any cause | Trial comparisons |
| Chemo and Endocrine Therapy vs Endocrine Therapy Alone: serious adverse events | Trial comparisons |
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/NCT01272037
GET https://conductscience.org/api/trials/v1/NCT01272037/results?page=2