Trial · NCT01509625
Retrospective Study Assessment Treatment Response Faslodex®( 500 mg)
NCT01509625, Completed, Isabel Blancas; results first posted 2016-06-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Retrospective Study Assessment Treatment Response Faslodex®( 500 mg). Trials, record NCT01509625. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01509625
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Retrospective Study Assessment Treatment Response Faslodex®( 500 mg)
- NCT number
- NCT01509625
- Status
- Completed
- Enrollment
- 272 participants, actual
- Lead sponsor
- Isabel Blancas
- Conditions
- Malignant Neoplasm of Breast Stage IV
- Interventions
- Fulvestrant
- First posted
- 2012-01-13
- Last updated
- 2016-06-01
- Results first posted
- 2016-06-01
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival | 22 months | Response to treatment with fulvestrant (Faslodex®) in terms of Progression Free Survival. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% or more increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Clinical Benefit Rate | 22 months | Response to treatment with fulvestrant in terms of Clinical Benefit Rate. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)\> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks). |
| Secondary | Overall Survival | 22 months | Response to treatment with fulvestrant in terms of Overall Survival |
| Secondary | Duration of Clinical Benefit | 22 months | Response to treatment with fulvestrant in terms of Duration of the Clinical Benefit. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)\> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks). |
| Secondary | Number of Participants With Adverse Events | 22 months | |
| Secondary | Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Visceral Metastases and Without Visceral Metastases | 22 months | Response to treatment with fulvestrant at the 500 mg/month and LD 500 dose in terms of PFS in a subgroup of patients with visceral metastases and without visceral metastases. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)\> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks). |
| Secondary | Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients After a First-line Hormonal Therapy Prior and in Subgroup of Patients After Two or More Prior Lines of Hormonal Therapy | 22 months | To assess the response to treatment with fulvestrant (Faslodex®) at the 500 mg/month and LD-500 dose in terms of PFS in a subgroup of patients after a first-line hormonal therapy prior and in subgroup of patients after two or more prior lines of hormonal therapy |
| Secondary | Response to Treatment With Fulvestrant in Terms of PFS in Subgroups of Patients With Her-2 Overexpression and Those Who do Not Over-express Her-2 | 22 months | To assess the response to treatment with fulvestrant at the 500 mg/month and LD 500 dose in terms of PFS in subgroups of patients with her-2 overexpression (+++ by immunohistochemistry or FISH positive) and those who do not over-express her-2 and to compare both groups. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or TC: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease)\> = 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion or the appearance of new lesions; Clinical Benefit = CR + PR+ Stable Disease (not progression of the disease for 24 or more weeks). |
| Secondary | Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Elevated Ki-67 and With Low Ki-67 | 22 months | To assess the response to treatment with fulvestrant (Faslodex®) at the 500 mg/month and LD-500 dose in terms of PFS in a subgroup of patients with elevated ki-67 (greater than or equal to 20%) and with low ki-67 and to compare both groups |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival | 22 months | month | MEDIAN | |
| SECONDARY | Clinical Benefit Rate | 22 months | percentage of patients | NUMBER | |
| SECONDARY | Overall Survival | 22 months | month | MEDIAN | |
| SECONDARY | Duration of Clinical Benefit | 22 months | For the study of the duration of the clinical benefit, only the patients that get a clinical benefit could be analyzed (this is the reason becasuse the number of participants analyzed was 140) | month | MEDIAN |
| SECONDARY | Number of Participants With Adverse Events | 22 months | percentage of patients | NUMBER | |
| SECONDARY | Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Visceral Metastases and Without Visceral Metastases | 22 months | We identified 272 patientes for the study but nine subjects were ineligible due to lack of information, leaving to 263 evaluable patients. | month | MEDIAN |
| SECONDARY | Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients After a First-line Hormonal Therapy Prior and in Subgroup of Patients After Two or More Prior Lines of Hormonal Therapy | 22 months | We identified 272 patientes for the study but nine subjects were ineligible due to lack of information, leaving to 263 evaluable patients. There were 5 patients that have not received previous tamoxifen or an aromatases inhibitor, so they are not included in one of these two groups. | month | MEDIAN |
| SECONDARY | Response to Treatment With Fulvestrant in Terms of PFS in Subgroups of Patients With Her-2 Overexpression and Those Who do Not Over-express Her-2 | 22 months | We identified 272 patientes for the study but nine subjects were ineligible due to lack of information, leaving to 263 evaluable patients. There were no information regarding HER2 status in 31 patients. | month | MEDIAN |
| SECONDARY | Response to Treatment With Fulvestrant in Terms of PFS in a Subgroup of Patients With Elevated Ki-67 and With Low Ki-67 | 22 months | We identified 272 patientes for the study but nine subjects were ineligible due to lack of information, leaving to 263 evaluable patients. There were no information regarding tumor ki67 expresion in 121 patients. | month | MEDIAN |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival | One Arm of Metastatic Breast Cancer Patients | 10.6 | 95% Confidence Interval 9.0 to 11.5 | month | |
| Clinical Benefit Rate | One Arm of Metastatic Breast Cancer Patients | 56.5 | percentage of patients | ||
| Overall Survival | One Arm of Metastatic Breast Cancer Patients | 43.2 | 95% Confidence Interval 37.0 to 49.2 | month | |
| Duration of Clinical Benefit | Patients With Clinical Benefit | 18.4 | 95% Confidence Interval 14.5 to 23.0 | month | |
| Number of Participants With Adverse Events | One Arm of Metastatic Breast Cancer Patients | any toxicity | 35.4 | 95% Confidence Interval 29.6 to 41.5 | percentage of patients |
| Number of Participants With Adverse Events | One Arm of Metastatic Breast Cancer Patients | local pain injection | 9.9 | 95% Confidence Interval 6.6 to 14.1 | percentage of patients |
| Number of Participants With Adverse Events | One Arm of Metastatic Breast Cancer Patients | Muscle-bone pain | 7.2 | 95% Confidence Interval 4.4 to 11.1 | percentage of patients |
| Number of Participants With Adverse Events | One Arm of Metastatic Breast Cancer Patients | Gastrointestinals disorders | 6.8 | 95% Confidence Interval 4.1 to 10.6 | percentage of patients |
| Number of Participants With Adverse Events | One Arm of Metastatic Breast Cancer Patients | Hot flashes | 6.1 | 95% Confidence Interval 3.5 to 9.7 | percentage of patients |
| Number of Participants With Adverse Events | One Arm of Metastatic Breast Cancer Patients | Urinary infection | 0.8 | 95% Confidence Interval 0.1 to 2.7 | percentage of patients |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | One Arm of Metastatic Breast Cancer Patients | 272 | |
| Overall Study | COMPLETED | One Arm of Metastatic Breast Cancer Patients | 263 | |
| Overall Study | NOT COMPLETED | One Arm of Metastatic Breast Cancer Patients | 9 |
Source ClinicalTrials.gov
Adverse events8
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 | Gastrointestinal disorders | Gastrointestinal disorders | One Arm of Metastatic Breast Cancer Patients | 18 | 263 | |
| other | Pain in inyection site | Injury, poisoning and procedural complications | One Arm of Metastatic Breast Cancer Patients | 26 | 263 | |
| other | Musculoskeletal disorders | Musculoskeletal and connective tissue disorders | One Arm of Metastatic Breast Cancer Patients | 19 | 263 | |
| other | Hot flushes | Skin and subcutaneous tissue disorders | One Arm of Metastatic Breast Cancer Patients | 16 | 263 | |
| other | Urinary infection | Infections and infestations | One Arm of Metastatic Breast Cancer Patients | 2 | 263 | |
| other | Weight gain | Endocrine disorders | One Arm of Metastatic Breast Cancer Patients | 1 | 263 | |
| other | Vaginitis | Infections and infestations | One Arm of Metastatic Breast Cancer Patients | 1 | 263 | |
| other | Joint pain | Musculoskeletal and connective tissue disorders | One Arm of Metastatic Breast Cancer Patients | 42 | 263 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | One Arm of Metastatic Breast Cancer Patients | ||
| Total, other adverse events | One Arm of Metastatic Breast Cancer Patients | 93 | 263 |
| Total, serious adverse events | One Arm of Metastatic Breast Cancer Patients | 0 | 263 |
Source ClinicalTrials.gov
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/NCT01509625
GET https://conductscience.org/api/trials/v1/NCT01509625/results?page=2