A Phase 2 interventional study of Doxorubicin and Cyclophosphamide in Breast Cancer and Invasive Breast Cancer, sponsored by National Cancer Center, Korea. Status unknown at 1 site in Korea, Republic of. Open to female participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-04-13.
Sponsored by National Cancer Center, Korea · Phase 2, Interventional, and Treatment
Among 162 studies testing letrozole in Breast Neoplasms — 22 open to participants now, 39 under way, 11 of them phase 3. Letrozole · Breast Neoplasms.
Among the 162 studies testing letrozole in Breast Neoplasms, this one is the 73rd largest by planned enrollment of the 159 interventional ones that give a count, is one of 7 that started in 2017, is one of 72 in phase 2, and was the 118th registered.
14,829 studies on the registry are indexed under Breast Neoplasms; 3,318 are open to participants now.
Browse Breast Neoplasms studies →22 of the 162 studies testing letrozole in Breast Neoplasms are open now, in 12 countries. Recruiting first, the newest first:
Fujian Cancer Hospital · Sites in China
Ages 18+ · Women only
Hebei Medical University Fourth Hospital · Sites in China
Ages 18–75 · Women only
Celcuity Inc · Sites in United States, Argentina, Australia and 22 more countries
Ages 18+
University of Chicago · Sites in Nigeria
Ages 18+ · Women only
Mridula George, MD · Sites in United States
Ages 60+ · Women only
By country, each count listing its studies:
Letrozole: first FDA approval 1997 (FEMARA). What it is approved for, and how studies give it, is on its page →
Of the 2,398 Breast Neoplasms studies recruiting now, 1,569 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.
This study: 19 Years to 70 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
162 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 22 · Phase 2 83 · Phase 3 45 · Phase 4 17
First in 1998; this study’s year is marked. 7 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 114 is above the median of 72 across 10,900 interventional studies indexed under Breast Neoplasms.
Median enrollment 95 across the 159 interventional studies. Of the 109 that completed or were terminated, 44 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
38 of 162 have an industry lead sponsor. The 10 most frequent:
National Cancer Center, Korea is the lead sponsor of 204 studies on the registry; 36 are open to participants now.
31 studies in Breast Neoplasms by National Cancer Center, Korea: 4 open now, 4 under way, none of them phase 3. Of 16 finished, 1 (6%) have results posted.
Among the 31 studies in Breast Neoplasms by National Cancer Center, Korea, this one is the 11th largest by planned enrollment of the 23 interventional ones that give a count, is the only one that started in 2017, is one of 15 in phase 2, and was the 24th registered.
National Cancer Center, Korea’s Breast Neoplasms studies by the year they started, since 2002.
8 of the studies testing letrozole in Breast Neoplasms that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05780567Phase 3Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer | 2026-12 |
| NCT04486911Shengjing HospitalPyrotinib Maleate, CDK4/6 Inhibitor and Letrozole in Combination for Stage II-III TPBC: a Phase II Trial | 2026-12-01 |
| NCT05286437National Cancer Centre, SingaporePhase II Lenvatinib and Pembrolizumab in Endocrine Resistant Breast Cancer With Letrozole | 2026-12-31 |
| NCT07492394Hebei Medical University Fourth HospitalDalpiciclib With or Without Entinostat and Letrozole in HR+/HER2- Early Breast Cancer | 2026-12-31 |
| NCT02562118National University Hospital, SingaporeNeoadjuvant Lenvatinib Combined With Letrozole in Hormone Receptor Positive Breast Cancer | 2027-01 |
Add all 8 to your calendar (.ics) → With an account.
Among the 162 studies testing letrozole in Breast Neoplasms, from their registry updates:
Among National Cancer Center, Korea’s 31 in Breast Neoplasms:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This is an exploratory interventional study that initiates chemotherapy with letrozole in patients with estrogen receptor positive/HER2-negative breast cancer preoperably.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Doxorubicin · Drug: Cyclophosphamide · Drug: Docetaxel · Drug: Letrozole · Drug: leuprorelin
60mg/m2 IV every 3 weeks for 4 cycles
600mg/m2 IV every 3 weeks for 4 cycles
75mg/m2 IV every 3 weeks for 4 cycles
2.5 mg once daily preoperably
3.75 mg SC every 4 weeks for premenopausal patients
pathologic complete remission (pCR)
pCR defined as no invasive residuals in breast and lymph nodes (ypT0/Tis, ypN0 \[MD Anderson definition\])
Time frame: within 6 weeks following the last dose of chemotherapy
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
Time frame: 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.
Time frame: 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
Time frame: within 6 weeks following the last dose of chemotherapy
Disease free survival
Disease-free survival (DFS) following operation.
Time frame: Patients will be followed up to 6 years
Plan to share: Undecided
No publications or documents are linked to this record.
Started May 2017 (actual). Primary completion is estimated for Nov 2023, 78 months after the start.
Of 1,070 non-industry phase 2 interventional studies under Breast Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 89. This study's planned 78 months is above that.
Counting every sponsor, half of 1,302 studies reached it within 51 months; a quarter within 30 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Letrozole
National Cancer Center, Korea →