Breast CancerPhase 2/3NCT03373708
Risk and Clinical Benefit of Chemotherapy and Intensive Endocrine Therapy for Luminal B1 Early-stage Breast Cancer
A Phase 2/3 study testing Epirubicin, Cyclophosphamide and Docetaxel in people with Breast Cancer and Chemotherapy, run by Zhiyong Yu.
Trial summary
Breast cancer is the most common female malignancy in the world, and the leading cause of cancer-associated mortalities among women. Hormone receptors (HR) including ER and PR are the main prognostic factor for breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Chemotherapy, Endocrine Breast Diseases
- What is being tested?
- Epirubicin, Cyclophosphamide and Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2017to 20 Dec 2019
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients were required to give written informed consent.
- Patients present with operable breast cancers that were diagnosed by histopathology and have no distant metastasis.
- Have no history of anti-cancer therapies including chemotherapy, radiation therapy, hormone therapy and surgical therapy
- Have normal cardiac functions by echocardiography
- ECOG scores are ≤ 0-1.
- Patients are disposed to practice contraception during the whole trial.
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- The results of patients' blood tests are as follows:
- Hb ≥ 90 g/L WBC ≥ 3.0×109/L Plt ≥ 100×109/L Neutrophils ≥ 1.5×109/L ALT and AST ≤ 2.5 times of normal upper limit. TBIL ≤ 1.5 times of normal upper limit. Creatinine ≤ 1.5 times of normal upper limit.
- ER+ Her2- early-stage breast cancer
Who cannot join
- Have other cancers at the same time or have the history of other cancers in recent five years, excluding the controlled skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of cervix.
- Active infections
- Severe non-cancerous diseases.
- The patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trails.
- Inflammatory breast cancer.
- Pregnant or lactational, or patients refuse to practice contraception during the whole trial.- Page 5 of 5 -
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- The patients are in some special conditions that they can't understand the written informed consent, such as they are demented or hawkish.
- Have allergic history of the chemotherapeutic agents.
- Bilateral breast cancers
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective Randomized Controlled Study on the Risk and Clinical Benefit of Chemotherapy and Intensive Endocrine Therapy for Luminal B1 Early-stage Breast Cancer
Breast cancer is the most common female malignancy in the world, and the leading cause of cancer-associated mortalities among women. Hormone receptors (HR) including ER and PR are the main prognostic factor for breast cancer patients. Breast cancer subtype was defined by ER, PR, HER2 and Ki67 status since the definition of intrinsic subtypes for breast cancer. Breast cancer which ER are positive have less aggressive and better long-term prognoses than other breast cancer subtype. Luminal B1 was definited as ER Positive, PR positive <20%, or Ki-67 ≥20% , and HER2-Negative. Although standard therapy to HR positive breast cancer is endocrine treatment, evidence reported that Luminal B1 breast cancers with lower PR expression are less sensitive to tamoxifen than luminal A breast cancers with higher PR expression, and the specific mechanism is not clear. We previously had a clinically analysed, and we found the Luminal B1 breast cancer had a significant proportion with 38%. Whether we need standard chemotherapy or chemotherapy based intensive endocrine therapy for those patients? In our research, we divided the patients with ER positive, PR negative, and HER-2 negative into two groups. One groups will be treated with 8 cycles of chemotherapy (EC×4-T×4). The other received 4 cycles of chemotherapy (TC×4) then will be given the intensive endocrine therapy (Goserelin acetate+Tamoxifen for young patients/Letrozole for postmenopausal patients). The primary endpoint is to assess disease-free survival (DFS) and overall survival (OS) in different regiments, the secondary endpoint is to assess the expression of female hormone levels. The correlation of the expression of female hormone levels with the clinical outcomes, so that the investigators could optimize adjuvant treatment regiment with luminal B1 breast cancer.
Read the detailed description
The trial is designed to investigative the risk and clinical benefit of chemotherapy and intensive endocrine therapy for Luminal B1 early-staged breast cancer. In this trial the investigators will randomly assign 200 primary breast cancer patients to receive four cycles of epirubicin and cyclophosphamide (EC) followed by four cycles of docetaxel(T), or four cycles of docetaxel and cyclophosphamide (TC) followed by intensive endocrine therapy (Goserelin acetate+Tamoxifen/Letrozole for young patients) . Patients with HER-2 positive was excluded. The patient's conditions will be assessed before, and after every four cycles of adjuvant chemotherapy to determine if there is any progression of the disease. The patient's conditions will be assessed every three months when they received the intensive endocrine therapy (Goserelin acetate+Tamoxifen for young patients/Letrozole for postmenopausal patients). Patients will be followed up for DFS and OS in different regiments, the secondary endpoint is to assess the expression of female hormone levels. The correlation of the expression of female hormone levels with the clinical outcomes, so that the investigators could optimize adjuvant treatment regiment with luminal B1 breast cancer.
- Conditions
- Breast Cancer, Chemotherapy, Endocrine Breast Diseases
- Being tested
- Epirubicin, Cyclophosphamide, Docetaxel, Goserelin acetate, Tamoxifen
- Medical subject headings
- Breast Neoplasms, Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpirubicinDrug
Also called Adriacin
100mg/m2
CyclophosphamideDrug
Also called Cyclophosphamide injection
600mg/m2
DocetaxelDrug
Also called Docetaxel injection
75mg/m2(TC), 100mg/m2(EC-T)
Goserelin acetateDrug
Also called Zoladex
3.6mg every month
TamoxifenDrug
Also called Nolvadex
10mg twice daily oral
LetrozoleDrug
Also called Femara
2.5mg every daily oral
| Study group | Role | What they receive |
|---|---|---|
| EC follow T group | Experimental | Epirubicin 100mg/m2 on day 1 cyclophosphamide 600mg/m2 on day1 every 2 weeks for four cycles followed by docetaxel 100mg/m2 on day 1 every 3 weeks for four cycles Receives: Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Docetaxel |
| TC follow endocrine | Experimental | Docetaxel 75mg/m2 on day 1 and cyclophosphamide 600mg/m2 on day 1 every 3 weeks for four cycles followed by goserelin acetate+tamoxifen for young patients/ letrozole for postmenopausal patients Receives: Drug: Cyclophosphamide; Drug: Docetaxel; Drug: Goserelin acetate; Drug: Tamoxifen; Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS)
To determine the percentage of disease-free survival (DFS) for the EC follow T arm and TC follow endocrine therapy arm separately.
Measured: 5 years
Secondary outcomes (2)
Expression of female hormone levels
To assess the association between the female hormone levels and the clinical outcomes
Measured: 5 years
Overall survival (OS)
To determine the percentage of Overall survival (OS) for the EC follow T arm and TC follow endocrine therapy arm separately.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start20 Dec 2017 (estimated)
- Primary completion20 Dec 2019 (estimated)
- Study completion20 Dec 2019 (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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhiyong Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhiyong Yu, Shandong Cancer Hospital and Institute
- Investigators
- Zhiyong Yu, PhD, Study chair, Shandong Cancer Hospital and InstituteZhaoyun Liu, MD, Principal investigator, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373708
- Sponsor's protocol ID
- ShandongCHI-03
- Status last verified
- Dec 2017
- First submitted
- 11 Dec 2017
- Last updated
- 18 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Study on the Risk and Clinical Benefit of Chemotherapy and Intensive Endocrine Therapy for Luminal B1 Early-stage Breast Cancer
- ClinicalTrials.gov ID
- NCT03373708
- Acronym / sponsor ID
- ShandongCHI-03
- Conditions
- Breast Cancer, Chemotherapy, Endocrine Breast Diseases
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zhiyong YuUniversity, hospital or other
- Study start
- 20 Dec 2017 (estimated)
- Primary completion
- 20 Dec 2019 (estimated)
- Study completion
- 20 Dec 2019 (estimated)
- First posted
- 14 Dec 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 the most common female malignancy in the world, and the leading cause of cancer-associated mortalities among women. Hormone receptors (HR) including ER and PR are the main prognostic factor for breast cancer patients. Breast cancer subtype was defined by ER, PR, HER2 and Ki67 status since the definition of intrinsic subtypes for breast cancer. Breast cancer which ER are positive have less aggressive and better long-term prognoses than other breast cancer subtype. Luminal B1 was definited as ER Positive, PR positive <20%, or Ki-67 ≥20% , and HER2-Negative. Although standard therapy to HR positive breast cancer is endocrine treatment, evidence reported that Luminal B1 breast cancers with lower PR expression are less sensitive to tamoxifen than luminal A breast cancers with higher PR expression, and the specific mechanism is not clear. We previously had a clinically analysed, and we found the Luminal B1 breast cancer had a significant proportion with 38%. Whether we need standard chemotherapy or chemotherapy based intensive endocrine therapy for those patients? In our research, we divided the patients with ER positive, PR negative, and HER-2 negative into two groups. One groups will be treated with 8 cycles of chemotherapy (EC×4-T×4). The other received 4 cycles of chemotherapy (TC×4) then will be given the intensive endocrine therapy (Goserelin acetate+Tamoxifen for young patients/Letrozole for postmenopausal patients). The primary endpoint is to assess disease-free survival (DFS) and overall survival (OS) in different regiments, the secondary endpoint is to assess the expression of female hormone levels. The correlation of the expression of female hormone levels with the clinical outcomes, so that the investigators could optimize adjuvant treatment regiment with luminal B1 breast cancer.
Detailed description
The trial is designed to investigative the risk and clinical benefit of chemotherapy and intensive endocrine therapy for Luminal B1 early-staged breast cancer. In this trial the investigators will randomly assign 200 primary breast cancer patients to receive four cycles of epirubicin and cyclophosphamide (EC) followed by four cycles of docetaxel(T), or four cycles of docetaxel and cyclophosphamide (TC) followed by intensive endocrine therapy (Goserelin acetate+Tamoxifen/Letrozole for young patients) . Patients with HER-2 positive was excluded. The patient's conditions will be assessed before, and after every four cycles of adjuvant chemotherapy to determine if there is any progression of the disease. The patient's conditions will be assessed every three months when they received the intensive endocrine therapy (Goserelin acetate+Tamoxifen for young patients/Letrozole for postmenopausal patients). Patients will be followed up for DFS and OS in different regiments, the secondary endpoint is to assess the expression of female hormone levels. The correlation of the expression of female hormone levels with the clinical outcomes, so that the investigators could optimize adjuvant treatment regiment with luminal B1 breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EC follow T group | Experimental | Drug: Epirubicin, Drug: Cyclophosphamide, Drug: DocetaxelEpirubicin 100mg/m2 on day 1 cyclophosphamide 600mg/m2 on day1 every 2 weeks for four cycles followed by docetaxel 100mg/m2 on day 1 every 3 weeks for four cycles |
| TC follow endocrine | Experimental | Drug: Cyclophosphamide, Drug: Docetaxel, Drug: Goserelin acetate, Drug: Tamoxifen, Drug: LetrozoleDocetaxel 75mg/m2 on day 1 and cyclophosphamide 600mg/m2 on day 1 every 3 weeks for four cycles followed by goserelin acetate+tamoxifen for young patients/ letrozole for postmenopausal patients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- All patients were required to give written informed consent.
- Patients present with operable breast cancers that were diagnosed by histopathology and have no distant metastasis.
- Have no history of anti-cancer therapies including chemotherapy, radiation therapy, hormone therapy and surgical therapy
- Have normal cardiac functions by echocardiography
- ECOG scores are ≤ 0-1.
Key exclusion criteria (9 listed)
- Have other cancers at the same time or have the history of other cancers in recent five years, excluding the controlled skin basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of cervix.
- Active infections
- Severe non-cancerous diseases.
- The patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trails.
- Inflammatory breast cancer.
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 |
|---|---|---|
| EpirubicinAlso: Adriacin100mg/m2 | Drug | EC follow T group |
| CyclophosphamideAlso: Cyclophosphamide injection600mg/m2 | Drug | EC follow T group, TC follow endocrine |
| DocetaxelAlso: Docetaxel injection75mg/m2(TC), 100mg/m2(EC-T) | Drug | EC follow T group, TC follow endocrine |
| Goserelin acetateAlso: Zoladex3.6mg every month | Drug | TC follow endocrine |
| TamoxifenAlso: Nolvadex10mg twice daily oral | Drug | TC follow endocrine |
| LetrozoleAlso: Femara2.5mg every daily oral | Drug | TC follow endocrine |
Primary outcome
Disease-free survival (DFS)
Time frame: 5 years
To determine the percentage of disease-free survival (DFS) for the EC follow T arm and TC follow endocrine therapy arm separately.
2 secondary outcomes
Expression of female hormone levels
Time frame: 5 years
Overall survival (OS)
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
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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.
Zhiyong Yu, PhD study chair
Shandong Cancer Hospital and Institute
Zhaoyun Liu, MD principal investigator
Shandong Cancer Hospital and Institute
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Epirubicin, Cyclophosphamide and Docetaxel in people with Breast Cancer and Chemotherapy, run by Zhiyong Yu.
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 9 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 18 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Zhiyong Yu, PhD (86-13355312277, drzhiyongyu@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (DFS) (time frame: 5 years). 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 18 Dec 2017.