Hormone Dependent NeoplasmsPhase 4HOTBreastNCT03111615
HOrmone Therapy Immediately After Histological Diagnosis of Breast Cancer
A Phase 4 study testing Aromatase Inhibitors in people with Hormone Dependent Neoplasms and Breast Cancer Female, run by Centro Hospitalar Lisboa Ocidental at 1 site in Portugal.
Trial summary
Breast Cancer is a public health issue worldwide. The time from diagnosis to treatment initiation varies from country to country and regionally within a country. Early diagnosis and prompt treatment initiation are key factors in patient survival rates. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Hormone Dependent Neoplasms, Breast Cancer Female
- What is being tested?
- Aromatase Inhibitors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePortugal
- Study dates
- 1 May 2018to 1 May 2020
- Phase
- Phase 4
- 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- informed consent
- <50 y.o.
- Pre-menopausal state
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hormone Therapy Initiation Immediately After Histological Diagnosis of Breast Cancer, Can it Make Any Difference?
Breast Cancer is a public health issue worldwide. The time from diagnosis to treatment initiation varies from country to country and regionally within a country. Early diagnosis and prompt treatment initiation are key factors in patient survival rates.
Currently there is a rising trend, with a high percentage of patients with "Luminal" like breast cancer only undergoing adjuvant endocrine therapy.
Authors argue that tumor biology alterations after introducing very early endocrine therapy might have a prognostic and therapeutic impact and should be studied.
Read the detailed description
Selected patients of female gender, above 50 y.o, and after a biopsy of Luminal-like Breast Cancer will go under aromatase inhibitor, from the diagnosis day till the surgical therapy to be decided (if so).In this study are going to be included patients that refuse surgical treatment, remaining this way in an "active surveillance". This last group is going to be randomised in order to recieve hormontherapy plus placebo vs hormontherapy plus acetolisalicilic acid.
In this way, authors want to investigate if:
- st This approach influences the tumor biology
- nd This approach influences tumor pathologic response and progression free survival.
- rd It is a valid approach and in which grade, for patients that refuse surgical treatment
- Conditions
- Hormone Dependent Neoplasms, Breast Cancer Female
- Being tested
- Aromatase Inhibitors
- Keywords
- Aromatase inhibitors, Luminal Breast Cancer neoadjuvant hormone therapy
- Medical subject headings
- Neoplasms, Hormone-Dependent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aromatase InhibitorsDrug
Also called Aromatase Inhibitor
Aromatase Inhibitor to start immediately after diagnosis of a Luminal Invasive Breast Carcinoma Patients will be given Letrozol 2.5 mg or Anastrazol1 mg, every 24H and all of them will be given Calcium + Vit D supplement.
Venlafaxin 75 mg is to be administrated cases indicated
| Study group | Role | What they receive |
|---|---|---|
| Aromatase Inhibitor group | Experimental | Female patients of 50 and above y.o. shall initiate hormone therapy (Letrozol 2.5 mg or Anastrazol 1 mg) immediately after the diagnosis until surgery. Receives: Drug: Aromatase Inhibitors |
| Control group | No intervention | Female patients of 50 and above y.o. that follow standard protocol (no pre-surgery (Letrozol 2.5 mg or Anastrazol 1 mg)) |
| Aromatase Inhibitor Active surveillance | Other | Female patients of 50 and above y.o. that refuse surgery and therefor follow standard protocol (only Letrozol 2.5mg or Anastrazol 1 mg) until disease progression, death or will of surgery In this subgroup we are going to include, under HT, female patients with CDis,that refuse the standard treatment with surgery plus eventual rt and/or ht Receives: Drug: Aromatase Inhibitors |
| Aromatase Inhibitor Active surveillance + aas | Other | emale patients of 50 and above y.o. that refuse surgery and therefor follow standard protocol (only Letrozol 2.5mg or Anastrazol 1 mg plus acetilsalicilic acid) until disease progression, death or will of surgery In this subgroup we are going to include, under HT, female patients with CDis,that refuse the standard treatment with surgery plus eventual rt and/or ht Receives: Drug: Aromatase Inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Biology
Effects of neoadjuvant aromatase inibitors on tumor biology in terms of RE,PR,Ki 67 measuring the after IA presurgical values
Measured: 6 weeks
Secondary outcomes (3)
Tumor Pathology response
Effects of neoadjuvant aromatase inibitors on tumor pathologic response , in terms of breast imaging re-avaliation before surgical intervention. For patients that refuse surgery or extend hormone therapy for other reasons
Measured: 6 weeks
Disease free survival
Effects of neoadjuvant aromatase inibitors on disease free survival the first, fifth and tenth years of follow-up
Measured: 1 5 and 10 years
Hormone treatment
Disease stability or progression under Hormone treatment in patients under active surveillance. Clinical and immaging follow up
Measured: 1 5 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start1 May 2018 (estimated)
- Primary completion1 May 2019 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone Dependent NeoplasmsStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Aromatase inibitor therapy to start immediately after biopsy results are available Letrozole 2.5mg or Anastrazol 1 mg
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar Lisboa Ocidental
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zacharoula Sidiropoulou, Centro Hospitalar Lisboa Ocidental
- Investigators
- Vasco Fonseca, MD, Principal investigator, CHLO Medical Oncology dptZacharoula Sidiropoulou, Principal investigator, CHLO Surgery dpt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111615
- Sponsor's protocol ID
- CentroHLOBreastUnit
- Acronym
- HOTBreast
- Status last verified
- Dec 2017
- First submitted
- 23 Feb 2017
- Last updated
- 5 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormone Therapy Initiation Immediately After Histological Diagnosis of Breast Cancer, Can it Make Any Difference?
- ClinicalTrials.gov ID
- NCT03111615
- Acronym / sponsor ID
- HOTBreast / CentroHLOBreastUnit
- Conditions
- Hormone Dependent Neoplasms, Breast Cancer Female
- Keywords
- Aromatase inhibitors, Luminal Breast Cancer neoadjuvant hormone therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Centro Hospitalar Lisboa OcidentalOther government
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 13 Apr 2017 (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.
Breast Cancer is a public health issue worldwide. The time from diagnosis to treatment initiation varies from country to country and regionally within a country. Early diagnosis and prompt treatment initiation are key factors in patient survival rates.
Currently there is a rising trend, with a high percentage of patients with "Luminal" like breast cancer only undergoing adjuvant endocrine therapy.
Authors argue that tumor biology alterations after introducing very early endocrine therapy might have a prognostic and therapeutic impact and should be studied.
Detailed description
Selected patients of female gender, above 50 y.o, and after a biopsy of Luminal-like Breast Cancer will go under aromatase inhibitor, from the diagnosis day till the surgical therapy to be decided (if so).In this study are going to be included patients that refuse surgical treatment, remaining this way in an "active surveillance". This last group is going to be randomised in order to recieve hormontherapy plus placebo vs hormontherapy plus acetolisalicilic acid.
In this way, authors want to investigate if:
- st This approach influences the tumor biology
- nd This approach influences tumor pathologic response and progression free survival.
- rd It is a valid approach and in which grade, for patients that refuse surgical treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- Aromatase inibitor therapy to start immediately after biopsy results are available Letrozole 2.5mg or Anastrazol 1 mg
| Arm | Type | Receives |
|---|---|---|
| Aromatase Inhibitor group | Experimental | Drug: Aromatase InhibitorsFemale patients of 50 and above y.o. shall initiate hormone therapy (Letrozol 2.5 mg or Anastrazol 1 mg) immediately after the diagnosis until surgery. |
| Control group | No intervention | –Female patients of 50 and above y.o. that follow standard protocol (no pre-surgery (Letrozol 2.5 mg or Anastrazol 1 mg)) |
| Aromatase Inhibitor Active surveillance | Other | Drug: Aromatase InhibitorsFemale patients of 50 and above y.o. that refuse surgery and therefor follow standard protocol (only Letrozol 2.5mg or Anastrazol 1 mg) until disease progression, death or will of surgery In this subgroup we are going to include, under HT, female patients with CDis,that refuse the standard treatment with surgery plus eventual rt and/or ht |
| Aromatase Inhibitor Active surveillance + aas | Other | Drug: Aromatase Inhibitorsemale patients of 50 and above y.o. that refuse surgery and therefor follow standard protocol (only Letrozol 2.5mg or Anastrazol 1 mg plus acetilsalicilic acid) until disease progression, death or will of surgery In this subgroup we are going to include, under HT, female patients with CDis,that refuse the standard treatment with surgery plus eventual rt and/or ht |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- informed consent
- <50 y.o.
- Pre-menopausal state
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 |
|---|---|---|
| Aromatase InhibitorsAlso: Aromatase InhibitorAromatase Inhibitor to start immediately after diagnosis of a Luminal Invasive Breast Carcinoma Patients will be given Letrozol 2.5 mg or Anastrazol1 mg, every 24H and all of them will be given Calcium + Vit D supplement. Venlafaxin 75 mg is to be administrated cases indicated | Drug | Aromatase Inhibitor Active surveillance, Aromatase Inhibitor Active surveillance + aas, Aromatase Inhibitor group |
Primary outcome
Tumor Biology
Time frame: 6 weeks
Effects of neoadjuvant aromatase inibitors on tumor biology in terms of RE,PR,Ki 67 measuring the after IA presurgical values
3 secondary outcomes
Tumor Pathology response
Time frame: 6 weeks
Disease free survival
Time frame: 1 5 and 10 years
Hormone treatment
Time frame: 1 5 and 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
- 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.
Vasco Fonseca, MD principal investigator
CHLO Medical Oncology dpt
Zacharoula Sidiropoulou principal investigator
CHLO Surgery dpt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aromatase Inhibitors in people with Hormone Dependent Neoplasms and Breast Cancer Female, run by Centro Hospitalar Lisboa Ocidental at 1 site in Portugal.
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 0 inclusion and 3 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 5 Dec 2017. 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 Portugal. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Vasco Fonseca, MD (0035121 043 1000, medicinavf@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor Biology (time frame: 6 weeks). 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 5 Dec 2017.