Highly Endocrine Responsive Operable Breast CancerPhase 2NCT03397537
Neoadjuvant Endocrine Therapy in Breast Cancer
A Phase 2 study testing Letrozole 2.5Mg Tablet and GnRH analogue in people with Highly Endocrine Responsive Operable Breast Cancer, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
The study aimed to compare the duration to complete or partial response (CR/PR) and the overall response rates (ORR) after six months of neoadjuvant endocrine therapy between pre-menopausal group and post-menopausal group with highly endocrine responsive operable mammary carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Highly Endocrine Responsive Operable Breast Cancer
- What is being tested?
- Letrozole 2.5Mg Tablet and GnRH analogue
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- Sep 2012to Jul 2017
- Phase
- Phase 2
- 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
Who may be able to join
- Females ≥18 years
- ER-positive (≥50%), PgR-positive (≥50% ), HER2-negative, and previously untreated, non-metastatic primary invasive BC.
- The tumour size had to be >1 cm.
Who cannot join
- male patients;
- patients with inflammatory breast cancer or distant metastasis;
- patients who were previously treatment treated with chemotherapy, radiation therapy or prior treatment with AIs or antiestrogens for breast cancer;
- patients with a second concomitant neoplasm;
- patients who could not meet the eligibility criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Letrozole as Neoadjuvant Treatment in Postmenopausal and Premenopausal Patients With Highly Endocrine Responsive Operable Breast Cancer
The study aimed to compare the duration to complete or partial response (CR/PR) and the overall response rates (ORR) after six months of neoadjuvant endocrine therapy between pre-menopausal group and post-menopausal group with highly endocrine responsive operable mammary carcinoma.
Read the detailed description
Estrogen receptor (ER) positive constitutes about 75% of all breast cancer(BC). Neoadjuvant endocrine therapy(NET) plays an important part in primary therapy of the hormone receptor (HR) -positive and HER2 -negative breast cancer. Recent studies revealed that the third-generation aromatase inhibitors (AIs) have superior ORR than tamoxifen in the HR-positive BC post-menopausal patients. The Z1031 trial showed that Letrozole obtained better ORR than the other two AIs anastrozole and exemestane after 16-18 weeks NET, although without any statistically significance.
In spite of these findings, the optimal duration of NET has not been fully elaborated, Although prolonged treatment might further reduce the tumor size. Further clinical benefits were achieved when the period of treatment of neoadjuvant letrozole prolonged more than three to four months. The 2015 St. Gallen International Consensus Conference recommended continuing neoadjuvant therapy in highly hormone-sensitive breast cancer for a minimum of 4-8 months. However, most studies aim to identify the excellent efficacy of the AIs compared with other drugs but not the duration of NET therapy. Antonio et al. suggest that the time to maximum clinical efficacy may be the optimal period of treatment for the patients; And the median time to maximum efficacy was 4.2 months (95% CI, 4.0-4.5). The present study evaluated the time to CR/PR and the ORR after 6 months of NET.
Previous clinical studies investigating NET mainly focused on post-menopausal women, data on pre-menopausal women is still relatively lacking due to the widely perception that more benefit may be achieved from neoadjuvant chemotherapy (NCT) among younger patients. The result of Z1031 trial showed superiority of neoadjuvant of AIs and promoted wider application of AIs as NET in the HR-positive post-menopausal women, and the clinical response rate (CRR) of letrozole was 74.8% after 16-18 weeks of treatment. The combination of AIs and GnRH analogue may be alternative for selected pre-menopausal patients. The STAGE trial showed the overall response rates of anastrozole plus goserelin in pre-menopausal patients was 70.4% after 6 months of NET. However, studies comparing the ORR and optimal duration of NET between pre-menopausal and post-menopausal patients were rare.
The purpose of the our research was to compare the duration to CR/PR and the ORR after 6 months of NET between pre-menopausal and post-menopausal women with highly endocrine responsive operable BC.
- Being tested
- Letrozole 2.5Mg Tablet, GnRH analogue
- Keywords
- Breast Neoplasms Endocrine-responsive Neoadjuvant Duration Letrozole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letrozole 2.5Mg TabletDrug
letrozole 2.5mg p.o.qd
GnRH analogueDrug
3.75 mg triptorelin im. q28d
| Study group | Role | What they receive |
|---|---|---|
| the postmenopausal | Other | 2.5 mg letrozole every day for six months Receives: Drug: Letrozole 2.5Mg Tablet |
| the premenopausal | Experimental | 2.5 mg letrozole daily along with a GnRH analogue for ovarian suppression, which was administered as an intramuscular injection of 3.75 mg triptorelin every 28 days for 6 months. Receives: Drug: Letrozole 2.5Mg Tablet; Drug: GnRH analogue |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
overall response rate
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study startSep 2012
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Highly Endocrine Responsive Operable Breast CancerStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03397537
- Sponsor's protocol ID
- 20170811
- Status last verified
- Sep 2012
- First submitted
- 25 Dec 2017
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Letrozole as Neoadjuvant Treatment in Postmenopausal and Premenopausal Patients With Highly Endocrine Responsive Operable Breast Cancer
- ClinicalTrials.gov ID
- NCT03397537
- Acronym / sponsor ID
- 20170811
- Keywords
- Breast Neoplasms Endocrine-responsive Neoadjuvant Duration Letrozole
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- Sep 2012 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 12 Jan 2018 (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.
The study aimed to compare the duration to complete or partial response (CR/PR) and the overall response rates (ORR) after six months of neoadjuvant endocrine therapy between pre-menopausal group and post-menopausal group with highly endocrine responsive operable mammary carcinoma.
Detailed description
Estrogen receptor (ER) positive constitutes about 75% of all breast cancer(BC). Neoadjuvant endocrine therapy(NET) plays an important part in primary therapy of the hormone receptor (HR) -positive and HER2 -negative breast cancer. Recent studies revealed that the third-generation aromatase inhibitors (AIs) have superior ORR than tamoxifen in the HR-positive BC post-menopausal patients. The Z1031 trial showed that Letrozole obtained better ORR than the other two AIs anastrozole and exemestane after 16-18 weeks NET, although without any statistically significance.
In spite of these findings, the optimal duration of NET has not been fully elaborated, Although prolonged treatment might further reduce the tumor size. Further clinical benefits were achieved when the period of treatment of neoadjuvant letrozole prolonged more than three to four months. The 2015 St. Gallen International Consensus Conference recommended continuing neoadjuvant therapy in highly hormone-sensitive breast cancer for a minimum of 4-8 months. However, most studies aim to identify the excellent efficacy of the AIs compared with other drugs but not the duration of NET therapy. Antonio et al. suggest that the time to maximum clinical efficacy may be the optimal period of treatment for the patients; And the median time to maximum efficacy was 4.2 months (95% CI, 4.0-4.5). The present study evaluated the time to CR/PR and the ORR after 6 months of NET.
Previous clinical studies investigating NET mainly focused on post-menopausal women, data on pre-menopausal women is still relatively lacking due to the widely perception that more benefit may be achieved from neoadjuvant chemotherapy (NCT) among younger patients. The result of Z1031 trial showed superiority of neoadjuvant of AIs and promoted wider application of AIs as NET in the HR-positive post-menopausal women, and the clinical response rate (CRR) of letrozole was 74.8% after 16-18 weeks of treatment. The combination of AIs and GnRH analogue may be alternative for selected pre-menopausal patients. The STAGE trial showed the overall response rates of anastrozole plus goserelin in pre-menopausal patients was 70.4% after 6 months of NET. However, studies comparing the ORR and optimal duration of NET between pre-menopausal and post-menopausal patients were rare.
The purpose of the our research was to compare the duration to CR/PR and the ORR after 6 months of NET between pre-menopausal and post-menopausal women with highly endocrine responsive operable BC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the postmenopausal | Other | Drug: Letrozole 2.5Mg Tablet2.5 mg letrozole every day for six months |
| the premenopausal | Experimental | Drug: Letrozole 2.5Mg Tablet, Drug: GnRH analogue2.5 mg letrozole daily along with a GnRH analogue for ovarian suppression, which was administered as an intramuscular injection of 3.75 mg triptorelin every 28 days for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Females ≥18 years
- ER-positive (≥50%), PgR-positive (≥50% ), HER2-negative, and previously untreated, non-metastatic primary invasive BC.
- The tumour size had to be >1 cm.
Key exclusion criteria (5 listed)
- male patients;
- patients with inflammatory breast cancer or distant metastasis;
- patients who were previously treatment treated with chemotherapy, radiation therapy or prior treatment with AIs or antiestrogens for breast cancer;
- patients with a second concomitant neoplasm;
- patients who could not meet the eligibility criteria.
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 |
|---|---|---|
| Letrozole 2.5Mg Tabletletrozole 2.5mg p.o.qd | Drug | the postmenopausal, the premenopausal |
| GnRH analogue3.75 mg triptorelin im. q28d | Drug | the premenopausal |
Primary outcome
ORR
Time frame: six months
overall response rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Letrozole 2.5Mg Tablet and GnRH analogue in people with Highly Endocrine Responsive Operable Breast Cancer, run by Guangdong Provincial People's Hospital at 1 site in China.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 17 Jan 2018. 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 China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: six months). 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 17 Jan 2018.