Breast Neoplasm FemaleNCT05140655
Effectiveness and Safety of Fulvestrant in Postmenopausal Women With Advanced Breast Cancer HR+, HER2-
An observational study of Breast Neoplasm Female, run by Dr. Reddy's Laboratories SAS at 1 site in Colombia.
Trial summary
A phase IV, single arm study will be performed in postmenopausal women with locally advanced or metastatic breast cancer. All patients included will receive fulvestrant from Dr. Reddy's Laboratories, in accordance with local practice and the regulatory authorization of the drug in Colombia. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm Female
- What is being tested?
- Fulvestrant
- How many people
- 40 participants
- Where
- 1 siteColombia
- Study dates
- 19 Apr 2021to 19 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Postmenopausal Women with Advanced Breast Cancer HR+, HER2-
Who may be able to join
- Postmenopausal women (defined as those with permanent cessation of menstruation for more than 12 months, regardless of whether their menopausal condition occurred naturally or was artificially induced), ambulatory or hospitalized
- Diagnosis of advanced breast cancer HR +, HER2-
- Positivity for hormone receptors (either estrogen, progesterone, or both).
- Negative for human epidermal growth factor receptor 2 (HER2).
- Acceptance of informed consent, if it is required by local regulatory standards.
Who cannot join
- History of previous treatment with fulvestrant.
- Concomitant treatment with antitumor drugs other than cyclin inhibitors (abemaciclib, palbociclib, ribociclib).
- Pregnancy.
- Lactation.
- Hypersensitivity to any of the excipients included in the complete formulation of fulvestrant from Dr. Reddy's Laboratories Limited.
- Renal insufficiency grade 4 or 5 (creatinine clearance <30 ml / min / 1.73 m2 according to the classification of the National Kidney Foundation).
- Hepatic failure (Child-Pugh C stage).
- Performance status ECOG ≥ 3.
Trial locations and contacts
1 site in 1 country.
Colombia1 site, 1 recruiting
- Recruiting
SOHEC
Valledupar, Cesar Department
Ray Manneh
About this study
Official title: Real-world Effectiveness and Safety of a Generic Fulvestrant Alone or in Combination With Cyclin Inhibitors in Postmenopausal Women With Advanced Breast Cancer HR+, HER2-, in Two Colombian Referral Centers
A phase IV, single arm study will be performed in postmenopausal women with locally advanced or metastatic breast cancer. All patients included will receive fulvestrant from Dr. Reddy's Laboratories, in accordance with local practice and the regulatory authorization of the drug in Colombia. This study will be carried out for 1 year and approximately 40 patients will be included in 2 research centers selected for its conduct.
Patients who meet the inclusion criteria and who do not have to be discarded from entering the study due to meeting any of the exclusion criteria, will be evaluated to determine the effectiveness and tolerability of the administration of Dr. Reddy's fulvestrant at a dose of 500 mg / month plus an additional indicated dose 14 days after the initial dose, for 12 months of follow-up or until disease progression or the appearance of unacceptable toxicity. The assessment of tolerability will be carried out based on the collection of data related to adverse events from the first dose administered.
- Conditions
- Breast Neoplasm Female
- Being tested
- Fulvestrant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FulvestrantDrug
Medicine for Advanced breast cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Objective response rate (ORR), defined as the proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST)percentage of patients with complete response or partial response) according to RECIST 1.1
Measured: Measured at 12 months
Clinical benefit rate (percentage of patients with complete response, partial response and stable disease)
CBR is the proportion of patients with a complete or partial response or with stable disease
Measured: Measured at 12 months
Overall survival rate
The percentage of people in a study or treatment group who are still alive for a certain period of time after they were diagnosed with or started treatment for a disease
Measured: 12 months
Disease-free survival rate
It is the percentage of individuals in the treatment group who are likely to be free of the signs and symptoms of a disease after a specified duration of time
Measured: 12 months
Secondary outcomes (4)
Describe the demographic characteristics of the patients included in the study
Measured: Measured at 12 months
Assess percentage of patients with adverse events (assessed by CTCAEv4.0) from the first administration and until the end of follow-up.
Common Terminology Criteria for Adverse Events
Measured: Measured at 12 months
Assess Percentage of patients with serious adverse events (assessed by CTCAEv4.0) from the first administration to the end of follow-up.
Common Terminology Criteria for Adverse Events
Measured: Measured at 12 months
Assess incidence, severity, and relationship to treatment defined by the investigator for reported adverse events.
Common Terminology Criteria for Adverse Events
Measured: Measured at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start19 Apr 2021
- Primary completion19 Apr 2022 (estimated)
- Study completion19 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Neoplasm FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ray Manneh, Principal investigator, SOHECJosé Lobatón, Principal investigator, IMAT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140655
- Sponsor's protocol ID
- DRLCOLCT001
- Status last verified
- Nov 2021
- First submitted
- 11 Nov 2021
- Last updated
- 1 Dec 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Effectiveness and Safety of a Generic Fulvestrant Alone or in Combination With Cyclin Inhibitors in Postmenopausal Women With Advanced Breast Cancer HR+, HER2-, in Two Colombian Referral Centers
- ClinicalTrials.gov ID
- NCT05140655
- Acronym / sponsor ID
- DRLCOLCT001
- Conditions
- Breast Neoplasm Female
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dr. Reddy's Laboratories SASIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 19 Apr 2022 (estimated)
- Study completion
- 19 Aug 2022 (estimated)
- First posted
- 1 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase IV, single arm study will be performed in postmenopausal women with locally advanced or metastatic breast cancer. All patients included will receive fulvestrant from Dr. Reddy's Laboratories, in accordance with local practice and the regulatory authorization of the drug in Colombia. This study will be carried out for 1 year and approximately 40 patients will be included in 2 research centers selected for its conduct.
Patients who meet the inclusion criteria and who do not have to be discarded from entering the study due to meeting any of the exclusion criteria, will be evaluated to determine the effectiveness and tolerability of the administration of Dr. Reddy's fulvestrant at a dose of 500 mg / month plus an additional indicated dose 14 days after the initial dose, for 12 months of follow-up or until disease progression or the appearance of unacceptable toxicity. The assessment of tolerability will be carried out based on the collection of data related to adverse events from the first dose administered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal Women with Advanced Breast Cancer HR+, HER2-
Key inclusion criteria (5 listed)
- Postmenopausal women (defined as those with permanent cessation of menstruation for more than 12 months, regardless of whether their menopausal condition occurred naturally or was artificially induced), ambulatory or hospitalized
- Diagnosis of advanced breast cancer HR +, HER2-
- Positivity for hormone receptors (either estrogen, progesterone, or both).
- Negative for human epidermal growth factor receptor 2 (HER2).
- Acceptance of informed consent, if it is required by local regulatory standards.
Key exclusion criteria (8 listed)
- History of previous treatment with fulvestrant.
- Concomitant treatment with antitumor drugs other than cyclin inhibitors (abemaciclib, palbociclib, ribociclib).
- Pregnancy.
- Lactation.
- Hypersensitivity to any of the excipients included in the complete formulation of fulvestrant from Dr. Reddy's Laboratories Limited.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FulvestrantMedicine for Advanced breast cancer | Drug | – |
Primary outcome
Objective response rate
Time frame: Measured at 12 months
Objective response rate (ORR), defined as the proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST)percentage of patients with complete response or partial response) according to RECIST 1.1
Clinical benefit rate (percentage of patients with complete response, partial response and stable disease)
Time frame: Measured at 12 months
CBR is the proportion of patients with a complete or partial response or with stable disease
Overall survival rate
Time frame: 12 months
The percentage of people in a study or treatment group who are still alive for a certain period of time after they were diagnosed with or started treatment for a disease
Disease-free survival rate
Time frame: 12 months
It is the percentage of individuals in the treatment group who are likely to be free of the signs and symptoms of a disease after a specified duration of time
4 secondary outcomes
Describe the demographic characteristics of the patients included in the study
Time frame: Measured at 12 months
Assess percentage of patients with adverse events (assessed by CTCAEv4.0) from the first administration and until the end of follow-up.
Time frame: Measured at 12 months
Assess Percentage of patients with serious adverse events (assessed by CTCAEv4.0) from the first administration to the end of follow-up.
Time frame: Measured at 12 months
Assess incidence, severity, and relationship to treatment defined by the investigator for reported adverse events.
Time frame: Measured at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ray Manneh principal investigator
SOHEC
José Lobatón principal investigator
IMAT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasm Female, run by Dr. Reddy's Laboratories SAS at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan Molina (3134981879, juanpablo@drreddys.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: Measured at 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2021.