Breast Cancer Stage IIPhase 2NeoTGNCT01352494
Neoadjuvant Chemotherapy With Docetaxel and Gemcitabine in Locally Advanced Breast Cancer
A Phase 2 study testing docetaxel and gemcitabine in people with Breast Cancer Stage II and Breast Cancer Stage III, run by Korean Breast Cancer Study Group at 1 site in South Korea.
Trial summary
The purpose of this study is to assess the response of docetaxel and gemcitabine in the neoadjuvant setting in women with locally advanced breast cancer. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Breast Cancer Stage II, Breast Cancer Stage III
- What is being tested?
- docetaxel and gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2011to May 2015
- 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 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged : 20~70 years
- World Health Organization (WHO) (Eastern Cooperative Oncology Group [ECOG]) performance status 0-2
- Patients with measurable lesion assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline
- Have given written informed consent and are available for prolonged follow-up
Who cannot join
- Patients with previous chemotherapy for recurrent breast cancer
- Breast cancer recurrence within 12 months after taxane treatment
- Her-2/neu expression breast cancer
- Patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell, squamous cell carcinoma of the skin.
- Brain metastasis
- uncontrolled infection, medically uncontrollable heart disease
- other serious medical illness or prior malignancies
- Pregnant or lactating women were excluded.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Surgery, the Catholic university of Korea, St. Vincent's hospital
Suwon, Gyeonggi-do
Young Jin Suh, M.D. Ph.D, 82-31-249-7114, youngjin.suh@gmail.com
About this study
Official title: A Multi-center Phase II Trial to Evaluate the Efficacy and Safety of Neoadjuvant Chemotherapy With DoceTaxel(Doxotel) and Gemcitabine(Gemcibine)in Locally Advanced Breast Cancer
The purpose of this study is to assess the response of docetaxel and gemcitabine in the neoadjuvant setting in women with locally advanced breast cancer.
Read the detailed description
Neoadjuvant chemotherapy is now standard for patients with locally advanced breast cancer, and this method of treatment has been extended to patients with earlier disease without affecting the treatment outcome. This single arm, multicenter phase II study was designed to evaluate the response rate, toxicity, progression free survival and tumor control rate of docetaxel and gemcitabine in the neoadjuvant setting with locally advanced breast cancer.
- Conditions
- Breast Cancer Stage II, Breast Cancer Stage III
- Being tested
- docetaxel, gemcitabine
- Keywords
- locally advanced breast cancer, docetaxel, gemcitabine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
Also called Doxotel®
docetaxel - 75 mg/m2, IV (in the vein), every 3 weeks, 4 cycles
gemcitabineDrug
Also called Gemcibine®
gemcitabine - 100 mg/m2, IV (in the vein) on day 1 and 8 day of each 28 day cycle, 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| docetaxel/gemcitabine | Experimental | All the patients are locally advanced breast cancer. Patients with a measurable lesion at chest CT. (at least 1 measurable lesion) Receives: Drug: docetaxel; Drug: gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission rate was assessed by pathologic examination after surgery.
Measured: 2 years
Secondary outcomes (4)
Type of surgery (Breast Conserving Rate)
Measured: 6 month
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 1 year
progression free survival
Measured: 2 years
quality of life
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2013 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer Stage IIStudies 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
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korean Breast Cancer Study Group
- Sponsor type
- University, hospital or other
- Investigators
- Young Jin Suh, M.D. Ph.D, Principal investigator, Department of Surgery, the Catholic university of Korea, St. Vincent's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01352494
- Sponsor's protocol ID
- KBCSG009
- Acronym
- NeoTG
- Status last verified
- May 2011
- First submitted
- 9 May 2011
- Last updated
- 27 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jeon YW, Kim TH, Youn HJ, Han S, Jung Y, Gwak G, Park YS, Kim JS, Suh YJ. A Multicenter Phase II Trial of Neoadjuvant Chemotherapy with Docetaxel and Gemcitabine in Locally Advanced Breast Cancer. J Breast Cancer. 2017 Dec;20(4):340-346. doi: 10.4048/jbc.2017.20.4.340. Epub 2017 Dec 19.
PubMed 29285038
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Phase II Trial to Evaluate the Efficacy and Safety of Neoadjuvant Chemotherapy With DoceTaxel(Doxotel) and Gemcitabine(Gemcibine)in Locally Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT01352494
- Acronym / sponsor ID
- NeoTG / KBCSG009
- Conditions
- Breast Cancer Stage II, Breast Cancer Stage III
- Keywords
- locally advanced breast cancer, docetaxel, gemcitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Korean Breast Cancer Study GroupUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2013 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 12 May 2011 (estimated)
- 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 purpose of this study is to assess the response of docetaxel and gemcitabine in the neoadjuvant setting in women with locally advanced breast cancer.
Detailed description
Neoadjuvant chemotherapy is now standard for patients with locally advanced breast cancer, and this method of treatment has been extended to patients with earlier disease without affecting the treatment outcome. This single arm, multicenter phase II study was designed to evaluate the response rate, toxicity, progression free survival and tumor control rate of docetaxel and gemcitabine in the neoadjuvant setting with locally advanced breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| docetaxel/gemcitabine | Experimental | Drug: docetaxel, Drug: gemcitabineAll the patients are locally advanced breast cancer. Patients with a measurable lesion at chest CT. (at least 1 measurable lesion) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women aged : 20~70 years
- World Health Organization (WHO) (Eastern Cooperative Oncology Group [ECOG]) performance status 0-2
- Patients with measurable lesion assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline
- Have given written informed consent and are available for prolonged follow-up
Key exclusion criteria (8 listed)
- Patients with previous chemotherapy for recurrent breast cancer
- Breast cancer recurrence within 12 months after taxane treatment
- Her-2/neu expression breast cancer
- Patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell, squamous cell carcinoma of the skin.
- Brain metastasis
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 |
|---|---|---|
| docetaxelAlso: Doxotel®docetaxel - 75 mg/m2, IV (in the vein), every 3 weeks, 4 cycles | Drug | docetaxel/gemcitabine |
| gemcitabineAlso: Gemcibine®gemcitabine - 100 mg/m2, IV (in the vein) on day 1 and 8 day of each 28 day cycle, 4 cycles | Drug | docetaxel/gemcitabine |
Primary outcome
Complete remission rate was assessed by pathologic examination after surgery.
Time frame: 2 years
4 secondary outcomes
Type of surgery (Breast Conserving Rate)
Time frame: 6 month
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 1 year
progression free survival
Time frame: 2 years
quality of life
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2011.
- Derived from this study: PubMed 29285038Jeon YW, Kim TH, Youn HJ, Han S, Jung Y, Gwak G, Park YS, Kim JS, Suh YJ. A Multicenter Phase II Trial of Neoadjuvant Chemotherapy with Docetaxel and Gemcitabine in Locally Advanced Breast Cancer. J Breast Cancer. 2017 Dec;20(4):340-346. doi: 10.4048/jbc.2017.20.4.340. Epub 2017 Dec 19.
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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.
Young Jin Suh, M.D. Ph.D principal investigator
Department of Surgery, the Catholic university of Korea, St. Vincent's hospital
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 docetaxel and gemcitabine in people with Breast Cancer Stage II and Breast Cancer Stage III, run by Korean Breast Cancer Study Group 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 4 inclusion and 8 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 27 May 2011. 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 Ku Sang Kim, M.D. (82-31-219-5200, ideakims@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission rate was assessed by pathologic examination after surgery. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01352494, which also lists 1 linked publication.
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 27 May 2011.