Breast CancerPhase 2NeoChAINCT03497702
Neo-adjuvant Chemotherapy With Letrozole in Patients With Estrogen Receptor Positive/HER-2 Negative Breast Cancer
A Phase 2 study testing Doxorubicin, Cyclophosphamide and Docetaxel in people with Breast Cancer and Invasive Breast Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
This is an exploratory interventional study that initiates chemotherapy with letrozole in patients with estrogen receptor positive/HER2-negative breast cancer preoperably. Read more about this study
- Who is it for?
- Ages 19 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Invasive Breast Cancer
- What is being tested?
- Doxorubicin, Cyclophosphamide and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 May 2017to Jan 2024
- 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 19 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically proven breast cancer patients who are candidate of neoadjuvant chemotherapy with AC followed by Docetaxel
- Age: 19-70 years
- ER or PR positive ,cT2-3N0 or cT1-3/N+ M0 (ER-positive ≥1% nuclear staining by immunohistochemistry , Allred score≥3 )
- Available FFPE tissue for biomarker study
- HER2-negative by ASCO/CAP guideline
- Patients who agree to adequate contraception
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- ECOG scores of 0-2
- Normal or acceptable kidney, liver, cardiovascular, and bone marrow functions
- Patients who provide consent
Who cannot join
- Inflammatory breast cancer
- Distant metastasis
- Cerebral vascular accidents including transient ischemic attack
- Pulmanary thromboembolism or deep vein thrombosis with 6 months; however, patients who received more than 6 weeks of anticoagulation within 6 months and remains asymptomatic are eligible.
- With a history of malignant tumor or complicated with other malignant tumors in addition to breast cancer, except for non-melanoma skin cancer, curatively resected early gastric cancer, differentiated thyoid cancer < 1 cm, or other cured malignant tumor without recurrence for at least 3 years
- Ejection Fraction <55% by MUGA scan / Echo CG
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- No available tissue for biomarker study
- Pregnant or lactating women
- Patients with other serious diseases or medical conditions: Pituitary adenoma, Malabsorption syndrome, Major resection of gastrointestinal tract, Corrected QT interval > 480 msec, Congestive heart failure or unstable angina pectoris, myocardial infarction, stent insertion, angioplasty, coronary bypass surgery, symptomatic peripheral artery disease within 6 months before the enrollment
- NYHA class III or IV congestive heart failure
- Uncontrolled hypertension and uncontrolled high-risk arrhythmia considered by the investigator
- Major surgery, major trauma, and/or unhealed wound, fracture, or ulcer within 4 weeks
- Acute hemorrhage or hemorrhagic tendency
- Obvious neurological or psychiatric disorders, including psychosis, epileptic dementia and other diseases which may affect the understanding and sign of the informed consent
- Uncontrolled acute infection
- Patients with allergic constitution and any known or suspected drug allergy
- Concurrent use of other investigational drugs; or participating in other clinical trials involving investigational drugs within 30 days before this study
- Patients with mental illness or other conditions affecting the patient compliance
- Not suitable for the trial considered by the investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
National Cancer Center
Goyang-si
Keun Seok Lee, MD, PhD
About this study
Official title: Phase II Study of Neo-adjuvant Chemotherapy With Letrozole in Patients With Estrogen Receptor Positive/HER-2 Negative Breast Cancer
This is an exploratory interventional study that initiates chemotherapy with letrozole in patients with estrogen receptor positive/HER2-negative breast cancer preoperably.
Read the detailed description
STUDY RATIONALE: Patients with ER+/HER2- operable breast cancers who are candiate of neoadjuant chemotherapy generally receive chemotherapy alone before operation, followed by adjuvant endocrine therapy. Because endocrine therapy is primarily delivered in the postoperative setting, the ability to add the efficacy of aromatase inhibitors combined with chemotherapy is lost. This study offers the unique opportunity to assess the synergistic or additive responsiveness of breast tumors to endocrine therapy plus chemotherapy while the tumors are still in vivo by treating patients with an aromatast inhibitor combined with chemotherapy before surgery and assessing pCR rates.
PRIMARY OBJECTIVE: The primary objective is to determine the frequency of pCR in breast and axilla.
- Conditions
- Breast Cancer, Invasive Breast Cancer
- Being tested
- Doxorubicin, Cyclophosphamide, Docetaxel, Letrozole, leuprorelin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxorubicinDrug
60mg/m2 IV every 3 weeks for 4 cycles
CyclophosphamideDrug
600mg/m2 IV every 3 weeks for 4 cycles
DocetaxelDrug
75mg/m2 IV every 3 weeks for 4 cycles
LetrozoleDrug
2.5 mg once daily preoperably
leuprorelinDrug
3.75 mg SC every 4 weeks for premenopausal patients
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Patients receive neoadjuvant chemotherapy (doxorubicin 60mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 every 3 weeks for 4 cycles followed by docetaxel 75mg/m2 IV on day 1 every 3 weeks for 4 cycles) plus letrozole with or without leuproelin depending on menopausal status Receives: Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Docetaxel; Drug: Letrozole; Drug: leuprorelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic complete remission (pCR)
pCR defined as no invasive residuals in breast and lymph nodes (ypT0/Tis, ypN0 [MD Anderson definition])
Measured: within 6 weeks following the last dose of chemotherapy
Secondary outcomes (4)
Adverse events
Frequency and severity of hematological and non-hematological adverse events and laboratory abnormalities according to Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Measured: during 6 months of neoadjuvant chemotherapy
Response rate
Overall objective clinical response rate = CR + PR rate, measured by MRI (or US) and assessed by RECIST criteria.
Measured: during 6 months of neoadjuvant chemotherapy
Downstaging to breast conserving surgery (BCS)
Ratio of the number of patients with breast conserving surgery converted from planned mastectomy over the number of patients with initially planned mastectomy
Measured: within 6 weeks following the last dose of chemotherapy
Disease free survival
Disease-free survival (DFS) following operation.
Measured: Patients will be followed up to 6 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 2018
- Study start8 May 2017
- Primary completionNov 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Keun Seok Lee, National Cancer Center, Korea
- Investigators
- Keun Seok Lee, MD, PhD, Principal investigator, National Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497702
- Sponsor's protocol ID
- NCC2017-0110
- Acronym
- NeoChAI
- Status last verified
- Apr 2018
- First submitted
- 18 Mar 2018
- Last updated
- 13 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Neo-adjuvant Chemotherapy With Letrozole in Patients With Estrogen Receptor Positive/HER-2 Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT03497702
- Acronym / sponsor ID
- NeoChAI / NCC2017-0110
- Conditions
- Breast Cancer, Invasive Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- 8 May 2017 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 13 Apr 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.
This is an exploratory interventional study that initiates chemotherapy with letrozole in patients with estrogen receptor positive/HER2-negative breast cancer preoperably.
Detailed description
STUDY RATIONALE: Patients with ER+/HER2- operable breast cancers who are candiate of neoadjuant chemotherapy generally receive chemotherapy alone before operation, followed by adjuvant endocrine therapy. Because endocrine therapy is primarily delivered in the postoperative setting, the ability to add the efficacy of aromatase inhibitors combined with chemotherapy is lost. This study offers the unique opportunity to assess the synergistic or additive responsiveness of breast tumors to endocrine therapy plus chemotherapy while the tumors are still in vivo by treating patients with an aromatast inhibitor combined with chemotherapy before surgery and assessing pCR rates.
PRIMARY OBJECTIVE: The primary objective is to determine the frequency of pCR in breast and axilla.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Doxorubicin, Drug: Cyclophosphamide, Drug: Docetaxel, Drug: Letrozole, Drug: leuprorelinPatients receive neoadjuvant chemotherapy (doxorubicin 60mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 every 3 weeks for 4 cycles followed by docetaxel 75mg/m2 IV on day 1 every 3 weeks for 4 cycles) plus letrozole with or without leuproelin depending on menopausal status |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Pathologically proven breast cancer patients who are candidate of neoadjuvant chemotherapy with AC followed by Docetaxel
- Age: 19-70 years
- ER or PR positive ,cT2-3N0 or cT1-3/N+ M0 (ER-positive ≥1% nuclear staining by immunohistochemistry , Allred score≥3 )
- Available FFPE tissue for biomarker study
- HER2-negative by ASCO/CAP guideline
Key exclusion criteria (19 listed)
- Inflammatory breast cancer
- Distant metastasis
- Cerebral vascular accidents including transient ischemic attack
- Pulmanary thromboembolism or deep vein thrombosis with 6 months; however, patients who received more than 6 weeks of anticoagulation within 6 months and remains asymptomatic are eligible.
- With a history of malignant tumor or complicated with other malignant tumors in addition to breast cancer, except for non-melanoma skin cancer, curatively resected early gastric cancer, differentiated thyoid cancer < 1 cm, or other cured malignant tumor without recurrence for at least 3 years
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 |
|---|---|---|
| Doxorubicin60mg/m2 IV every 3 weeks for 4 cycles | Drug | Experimental |
| Cyclophosphamide600mg/m2 IV every 3 weeks for 4 cycles | Drug | Experimental |
| Docetaxel75mg/m2 IV every 3 weeks for 4 cycles | Drug | Experimental |
| Letrozole2.5 mg once daily preoperably | Drug | Experimental |
| leuprorelin3.75 mg SC every 4 weeks for premenopausal patients | Drug | Experimental |
Primary outcome
pathologic complete remission (pCR)
Time frame: within 6 weeks following the last dose of chemotherapy
pCR defined as no invasive residuals in breast and lymph nodes (ypT0/Tis, ypN0 [MD Anderson definition])
4 secondary outcomes
Adverse events
Time frame: during 6 months of neoadjuvant chemotherapy
Response rate
Time frame: during 6 months of neoadjuvant chemotherapy
Downstaging to breast conserving surgery (BCS)
Time frame: within 6 weeks following the last dose of chemotherapy
Disease free survival
Time frame: Patients will be followed up to 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.
- Individual participant dataSharing planned: Undecided
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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.
Keun Seok Lee, MD, PhD principal investigator
National Cancer Center
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 Doxorubicin, Cyclophosphamide and Docetaxel in people with Breast Cancer and Invasive Breast Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
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 9 inclusion and 19 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 13 Apr 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keun Seok Lee, MD, PhD (+82-31-920-1220, kslee@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathologic complete remission (pCR) (time frame: within 6 weeks following the last dose of chemotherapy). 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 13 Apr 2018.