The Neoadjuvant TherapyPhase 2/3NCT04753177
The Neoadjuvant Combined Hormone Therapy in Premenopausal Women With Locally Advanced ER+/HER2- Breast Cancer
A Phase 2/3 study testing Ribocyclib, fulvestrant, triptorelin and Doxorubicin, cyclophosphamide, paclitaxel in people with The Neoadjuvant Therapy, run by Saint Petersburg State Budgetary Healthcare Institution, City Clinical Oncology Dispensary at 1 site in Russia.
Trial summary
Breast cancer take a leading position in the structure of morbidity and mortality from malignant tumors among women. Today the interest of many scientists and pharmaceutical companies is focused on the study of metastatic breast cancer forms. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- The Neoadjuvant Therapy
- What is being tested?
- Ribocyclib, fulvestrant, triptorelin and Doxorubicin, cyclophosphamide, paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteRussia
- Study dates
- 28 Jan 2021to 28 Jan 2024
- Phase
- Phase 2/3
- 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 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female
- Age ≥ 18 years
- Women with a newly diagnosed breast cancer who have not previously received specific treatment, with a tumor stage: cT1-3N1-2M0.
- Immunohistochemical tumor markers: ER-positive (ER+ is defined ≥ 10% and/or and Allred of 2 or more); HER2 negative (HER2 negative is defined as having an IHC of 1+ without ISH OR IHC 2+ and ISH non-amplified with ratio less than 2.0 and if reported, average HER2 copy number < 4 signals/cells OR ISH non-amplified with ratio less than 2.0 and if reported, average HER2 copy number < 4 signals/cells (without IHC)
- Premenopausal women.
- Signed consent to participate in a clinical trial.
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- The consent of the patient to carry out, if possible, organ-preserving surgery with previous radiation therapy.
- General state of ECOG (PS) 0 or 1.
- Adequate Bone Marrow Function including:
- Absolute Neutrophil Count (ANC) ≥1500/μL or ≥1.5 x109/L; Platelets ≥100000/μL or ≥100 x 109/L; Hemoglobin ≥ 9 g/dL.
- Adequate Renal Function including: Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or estimated creatinine clearance ≥ 60 ml/min as calculated using the method standard for the institution.
- Adequate Liver Function, including all of the following parameters:
- Total serum bilirubin ≤ 1.0 x ULN unless the subject has documented Gilbert syndrome (in which case up to 3 x ULN is acceptable) ; Aspartate and Alanine Aminotransferase (AST and ALT) ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN.
- Female subjects of child bearing potential and their partners, who are sexually active, must agree to the use of two highly effective forms of contraception in combination throughout the period of taking study treatment and for at least 90 days after last dose of study drug, or they must totally/truly abstain from any form of sexual intercourse. Use of oral hormonal contraceptive agents in this study is not permitted.
- Absence of mutations in the BRCA1 and BRCA2 genes (revealed by PCR blood analysis)
- Providing histological materials to determine the status of mutations in the PIK3CA gene
Who cannot join
- Primary multiple synchronous tumors (except for detected basal multiple cancer of the skin or cervix in situ, which can be radically treated without adjuvant treatment for breast cancer)
- HIV positive status
- Known hypersensitivity to study drugs or excipients.
- Pregnancy and lactation
- Any chronic disease in the acute stage
Trial locations and contacts
1 site in 1 country.
Russia1 site
Saint Petersburg State Budgetary Healthcare Institution, City Clinical Oncology Dispensary
St-Peterburg, 191456
About this study
Breast cancer take a leading position in the structure of morbidity and mortality from malignant tumors among women.
Today the interest of many scientists and pharmaceutical companies is focused on the study of metastatic breast cancer forms. While we obtain little experimental data and practical research about the treatment of locally advanced forms.
Read more
In this regard, the study of new neoadjuvant drug therapy regimen for estrogen-receptor positive breast cancer in premenopausal woman is very relevant.
The proposed research will be the absolutely innovative investigation worldwide.
The study will consist of two modes of treatment, combined hormone therapy with CDK4/6-ingibitors and chemotherapy (the control), each replicated four times in a randomized, complete block design.
This research aims to improve the results of treatment, namely to increase the percentage of successfully treated patients and reduce toxicity from treatment.
Primary study endpoints will include the frequency of objective response and complete pathomorphological response (according to the Miller-Payne classification).
Secondary endpoints will include a decrease of the Ki67 level in postoperative material compared to primary biopsy, the frequency of organ-preserving operation after neoadjuvant treatment and quality of life.
Study hypothesis: neoadjuvant combined hormone therapy with CDK4/6-ingibitors in premenopausal women with luminal breast cancer leads to at least the same results as neoadjuvant chemotherapy, but with less toxicity.
- Conditions
- The Neoadjuvant Therapy
- Being tested
- Ribocyclib, fulvestrant, triptorelin, Doxorubicin, cyclophosphamide, paclitaxel
- Keywords
- combined hormone therapy, CDK4/6-ingibitors, fulvestrant, gozerelin, triptorelin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ribocyclib, fulvestrant, triptorelinDrug
Neoadjuvant treatment will last 24 weeks in both groups. A follow-up examination will be carried out every 8 weeks. In the group of combined hormone therapy, repeate cor-biopsy of the tumor is planned to assess the Ki-67
Doxorubicin, cyclophosphamide, paclitaxelDrug
Neoadjuvant treatment will last 24 weeks in both groups. A follow-up examination will be carried out every 8 weeks. In the group of combined hormone therapy, repeate cor-biopsy of the tumor is planned to assess the Ki-67
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant combined hormone therapy | Experimental | Ribocyclib, fulvestrant, triptorelin Receives: Drug: Ribocyclib, fulvestrant, triptorelin; Drug: Doxorubicin, cyclophosphamide, paclitaxel |
| Chemotherapy (the control) | Active comparator | doxorubicin, cyclophosphamide, paclitaxel Receives: Drug: Ribocyclib, fulvestrant, triptorelin; Drug: Doxorubicin, cyclophosphamide, paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of objective response
according to the results of ultrasound of the mammary glands and / or mammography
Measured: 24 weeks
complete pathomorphological response
according to the Miller-Payne classification
Measured: 24 weeks
Secondary outcomes (3)
change of the Ki67 level in postoperative material compared to primary biopsy
compared to primary biopsy
Measured: 24 weeks
the frequency of organ-preserving operation after neoadjuvant treatment
in bouth groups
Measured: 24 weeks
quality of life
The quality of life questionnaire EORTC QLQ-C30
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start28 Jan 2021
- Primary completion28 Jan 2023 (estimated)
- Study completion28 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Neoadjuvant TherapyStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Petersburg State Budgetary Healthcare Institution, City Clinical Oncology Dispensary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753177
- Sponsor's protocol ID
- 12345
- Status last verified
- Feb 2021
- First submitted
- 6 Feb 2021
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neoadjuvant Combined Hormone Therapy in Premenopausal Women With Locally Advanced ER+/HER2- Breast Cancer
- ClinicalTrials.gov ID
- NCT04753177
- Acronym / sponsor ID
- 12345
- Conditions
- The Neoadjuvant Therapy
- Keywords
- combined hormone therapy, CDK4/6-ingibitors, fulvestrant, gozerelin, triptorelin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Saint Petersburg State Budgetary Healthcare Institution, City Clinical Oncology DispensaryUniversity, hospital or other
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 28 Jan 2023 (estimated)
- Study completion
- 28 Jan 2024 (estimated)
- First posted
- 15 Feb 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.
Breast cancer take a leading position in the structure of morbidity and mortality from malignant tumors among women.
Today the interest of many scientists and pharmaceutical companies is focused on the study of metastatic breast cancer forms. While we obtain little experimental data and practical research about the treatment of locally advanced forms.
In this regard, the study of new neoadjuvant drug therapy regimen for estrogen-receptor positive breast cancer in premenopausal woman is very relevant.
The proposed research will be the absolutely innovative investigation worldwide.
The study will consist of two modes of treatment, combined hormone therapy with CDK4/6-ingibitors and chemotherapy (the control), each replicated four times in a randomized, complete block design.
This research aims to improve the results of treatment, namely to increase the percentage of successfully treated patients and reduce toxicity from treatment.
Primary study endpoints will include the frequency of objective response and complete pathomorphological response (according to the Miller-Payne classification).
Secondary endpoints will include a decrease of the Ki67 level in postoperative material compared to primary biopsy, the frequency of organ-preserving operation after neoadjuvant treatment and quality of life.
Study hypothesis: neoadjuvant combined hormone therapy with CDK4/6-ingibitors in premenopausal women with luminal breast cancer leads to at least the same results as neoadjuvant chemotherapy, but with less toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant combined hormone therapy | Experimental | Drug: Ribocyclib, fulvestrant, triptorelin, Drug: Doxorubicin, cyclophosphamide, paclitaxelRibocyclib, fulvestrant, triptorelin |
| Chemotherapy (the control) | Active comparator | Drug: Ribocyclib, fulvestrant, triptorelin, Drug: Doxorubicin, cyclophosphamide, paclitaxeldoxorubicin, cyclophosphamide, paclitaxel |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Female
- Age ≥ 18 years
- Women with a newly diagnosed breast cancer who have not previously received specific treatment, with a tumor stage: cT1-3N1-2M0.
- Immunohistochemical tumor markers: ER-positive (ER+ is defined ≥ 10% and/or and Allred of 2 or more); HER2 negative (HER2 negative is defined as having an IHC of 1+ without ISH OR IHC 2+ and ISH non-amplified with ratio less than 2.0 and if reported, average HER2 copy number < 4 signals/cells OR ISH non-amplified with ratio less than 2.0 and if reported, average HER2 copy number < 4 signals/cells (without IHC)
- Premenopausal women.
Key exclusion criteria (5 listed)
- Primary multiple synchronous tumors (except for detected basal multiple cancer of the skin or cervix in situ, which can be radically treated without adjuvant treatment for breast cancer)
- HIV positive status
- Known hypersensitivity to study drugs or excipients.
- Pregnancy and lactation
- Any chronic disease in the acute stage
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 |
|---|---|---|
| Ribocyclib, fulvestrant, triptorelinNeoadjuvant treatment will last 24 weeks in both groups. A follow-up examination will be carried out every 8 weeks. In the group of combined hormone therapy, repeate cor-biopsy of the tumor is planned to assess the Ki-67 | Drug | Chemotherapy (the control), Neoadjuvant combined hormone therapy |
| Doxorubicin, cyclophosphamide, paclitaxelNeoadjuvant treatment will last 24 weeks in both groups. A follow-up examination will be carried out every 8 weeks. In the group of combined hormone therapy, repeate cor-biopsy of the tumor is planned to assess the Ki-67 | Drug | Chemotherapy (the control), Neoadjuvant combined hormone therapy |
Primary outcome
frequency of objective response
Time frame: 24 weeks
according to the results of ultrasound of the mammary glands and / or mammography
complete pathomorphological response
Time frame: 24 weeks
according to the Miller-Payne classification
3 secondary outcomes
change of the Ki67 level in postoperative material compared to primary biopsy
Time frame: 24 weeks
the frequency of organ-preserving operation after neoadjuvant treatment
Time frame: 24 weeks
quality of life
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Individual participant dataSharing planned: Undecided. yes
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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.
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 2/3 study testing Ribocyclib, fulvestrant, triptorelin and Doxorubicin, cyclophosphamide, paclitaxel in people with The Neoadjuvant Therapy, run by Saint Petersburg State Budgetary Healthcare Institution, City Clinical Oncology Dispensary at 1 site in Russia.
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 16 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: status not confirmed, as of the sponsor's last update on 15 Feb 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 Russia. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
frequency of objective response (time frame: 24 weeks). The study lists 2 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 15 Feb 2021.