Breast CancerPhase 2DA-PETNCT01396655
PET in Breast Cancer Receiving Neoadjuvant Chemotherapy
A Phase 2 study testing docetaxel (75 mg/m2) and doxorubicin (50 mg/m2) in people with Breast Cancer, run by Seoul National University Hospital.
Trial summary
Prognostic factors in locally advanced breast cancer treated with neoadjuvant chemotherapy differ from those of early breast cancer. The purpose of this study was to identify the clinical significance of potential predictive and prognostic factors including serial FDG PET/CT in breast cancer patients treated by… Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- docetaxel (75 mg/m2) and doxorubicin (50 mg/m2)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Jul 2006to Jun 2011
- 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
- pathologically-confirmed breast cancer by core needle biopsy,
- initial clinical stage II or III,
- objective measurable lesion,
- ECOG performance 0~2,
- previously untreated,
- adequate bone marrow, hepatic, cardiac, and renal functions
- age 20~70
- agreement with this trial, and written informed consent
Who cannot join
- history of other cancer
- active infection
- pregnancy
- psychologic disease
- uncontrolled heart diseases
- male
About this study
Official title: Analysis of Clinical Outcome, Predictive and Prognostic Factors of Therapeutic Responses in Patients Who Treated With Doxorubicin & Docetaxel Neoadjuvant Chemotherapy in Clinical Stage II or III Breast Cancer
Prognostic factors in locally advanced breast cancer treated with neoadjuvant chemotherapy differ from those of early breast cancer.
The purpose of this study was to identify the clinical significance of potential predictive and prognostic factors including serial FDG PET/CT in breast cancer patients treated by neoadjuvant chemotherapy.
- Conditions
- Breast Cancer
- Being tested
- docetaxel (75 mg/m2) and doxorubicin (50 mg/m2)
- Keywords
- breast cancer, neoadjuvant chemotherapy, molecular marker, FDG PET, locally advanced breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxel (75 mg/m2) and doxorubicin (50 mg/m2)Drug
The chemotherapeutic regimen consisted of docetaxel (75 mg/m2) and doxorubicin (50 mg/m2) by intravenous infusion every 3 weeks. After three cycles of neoadjuvant chemotherapy, the patients were re-evaluated for response and underwent curative surgery. Radiologic response was evaluated using breast magnetic resonance imaging (MRI) for the primary breast tumor and chest computed tomography (CT) for axillary, supraclavicular, internal mammary lymph nodes with RECIST criteria. Both breast MRI and chest CT were performed in all the 78 patients. Subsequently, the patients received three more cycles of docetaxel and doxorubicin as an adjuvant chemotherapy, followed by hormonal or radiation therapy, if indicated.
| Study group | Role | What they receive |
|---|---|---|
| docetaxel + doxorubicin | Experimental | The chemotherapeutic regimen consisted of docetaxel (75 mg/m2) and doxorubicin (50 mg/m2) by intravenous infusion every 3 weeks. Receives: Drug: docetaxel (75 mg/m2) and doxorubicin (50 mg/m2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic complete response
The primary end point of this trial was evaluating pathologic complete response (pCR) rate. After 3 cycles of neoadjuvant chemotherapy, patients were undertook breast surgery. Using post operative pathology specimen, we evaluated pathologic response and calculated pCR rate.
Measured: after completion of 3 cycles of neoadjuvant chemotherapy (9 weeks after initiation of chemotherapy)
Secondary outcomes (4)
survival (Relapse-free survival, overall survival)
Relapse-free survival, overall survival were estimated by Kaplan-Meier product limit methods
Measured: 2years , 3 years and 5 years after initiation of neoadjuvant chemotherapy
early metabolic response
Early metabolic response were evaluated by serial FDG PET/CT before and after 1cycle of neoadjuvant chemotherapy (15th days after 1cycle). Declining of SUV were calculated
Measured: before chemotherapy, and after 1cycle of neoadjuvant chemotherapy (15th days after 1cycle)
predictive factors
Predictive factors for pathologic complete response were analyzed using univariate and multivariate logistic regression analysis
Measured: after completion of 3 cycles of neoadjuvant chemotherapy (9 weeks after initiation of chemotherapy)
hematologic toxicity
Hematologic toxicities are evaluated every q 3weeks during chemotherapy. Neutropenia,thrombocytopenia, and anemia are evaluated during chemotherapy (per cycles) by NCI CTCAE v3.0 criteria.
Measured: every q 3weeks during chemotherapy (up to 24 weeks from initiation of chemotherapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startJul 2006
- Primary completionSep 2008
- Study completionJun 2011
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 CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seock-Ah Im, Seoul National University Hospital
- Investigators
- Bhumsuk Keam, MD, Principal investigator, Seoul National University HospitalSeock-Ah Im, MD PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01396655
- Sponsor's protocol ID
- DA-PET-2010-0022299
- Acronym
- DA-PET
- Status last verified
- Jul 2011
- First submitted
- 16 Jun 2011
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Keam B, Im SA, Koh Y, Han SW, Oh DY, Cho N, Kim JH, Han W, Kang KW, Moon WK, Kim TY, Park IA, Noh DY, Chung JK, Bang YJ. Early metabolic response using FDG PET/CT and molecular phenotypes of breast cancer treated with neoadjuvant chemotherapy. BMC Cancer. 2011 Oct 20;11:452. doi: 10.1186/1471-2407-11-452.
PubMed 22011459
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Clinical Outcome, Predictive and Prognostic Factors of Therapeutic Responses in Patients Who Treated With Doxorubicin & Docetaxel Neoadjuvant Chemotherapy in Clinical Stage II or III Breast Cancer
- ClinicalTrials.gov ID
- NCT01396655
- Acronym / sponsor ID
- DA-PET / DA-PET-2010-0022299
- Conditions
- Breast Cancer
- Keywords
- breast cancer, neoadjuvant chemotherapy, molecular marker, FDG PET, locally advanced breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 19 Jul 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.
Prognostic factors in locally advanced breast cancer treated with neoadjuvant chemotherapy differ from those of early breast cancer.
The purpose of this study was to identify the clinical significance of potential predictive and prognostic factors including serial FDG PET/CT in breast cancer patients treated by neoadjuvant chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| docetaxel + doxorubicin | Experimental | Drug: docetaxel (75 mg/m2) and doxorubicin (50 mg/m2)The chemotherapeutic regimen consisted of docetaxel (75 mg/m2) and doxorubicin (50 mg/m2) by intravenous infusion every 3 weeks. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- pathologically-confirmed breast cancer by core needle biopsy,
- initial clinical stage II or III,
- objective measurable lesion,
- ECOG performance 0~2,
- previously untreated,
Key exclusion criteria (6 listed)
- history of other cancer
- active infection
- pregnancy
- psychologic disease
- uncontrolled heart diseases
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 |
|---|---|---|
| docetaxel (75 mg/m2) and doxorubicin (50 mg/m2)The chemotherapeutic regimen consisted of docetaxel (75 mg/m2) and doxorubicin (50 mg/m2) by intravenous infusion every 3 weeks. After three cycles of neoadjuvant chemotherapy, the patients were re-evaluated for response and underwent curative surgery. Radiologic response was evaluated using breast magnetic resonance imaging (MRI) for the primary breast tumor and chest computed tomography (CT) for axillary, supraclavicular, internal mammary lymph nodes with RECIST criteria. Both breast MRI and chest CT were performed in all the 78 patients. Subsequently, the patients received three more cycles of docetaxel and doxorubicin as an adjuvant chemotherapy, followed by hormonal or radiation therapy, if indicated. | Drug | docetaxel + doxorubicin |
Primary outcome
pathologic complete response
Time frame: after completion of 3 cycles of neoadjuvant chemotherapy (9 weeks after initiation of chemotherapy)
The primary end point of this trial was evaluating pathologic complete response (pCR) rate. After 3 cycles of neoadjuvant chemotherapy, patients were undertook breast surgery. Using post operative pathology specimen, we evaluated pathologic response and calculated pCR rate.
4 secondary outcomes
survival (Relapse-free survival, overall survival)
Time frame: 2years , 3 years and 5 years after initiation of neoadjuvant chemotherapy
early metabolic response
Time frame: before chemotherapy, and after 1cycle of neoadjuvant chemotherapy (15th days after 1cycle)
predictive factors
Time frame: after completion of 3 cycles of neoadjuvant chemotherapy (9 weeks after initiation of chemotherapy)
hematologic toxicity
Time frame: every q 3weeks during chemotherapy (up to 24 weeks from initiation of chemotherapy)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Derived from this study: PubMed 22011459Keam B, Im SA, Koh Y, Han SW, Oh DY, Cho N, Kim JH, Han W, Kang KW, Moon WK, Kim TY, Park IA, Noh DY, Chung JK, Bang YJ. Early metabolic response using FDG PET/CT and molecular phenotypes of breast cancer treated with neoadjuvant chemotherapy. BMC Cancer. 2011 Oct 20;11:452. doi: 10.1186/1471-2407-11-452.
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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.
Bhumsuk Keam, MD principal investigator
Seoul National University Hospital
Seock-Ah Im, MD PhD principal investigator
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing docetaxel (75 mg/m2) and doxorubicin (50 mg/m2) in people with Breast Cancer, run by Seoul National University Hospital.
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 8 inclusion and 6 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: finished, as of the sponsor's last update on 17 Apr 2025. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
pathologic complete response (time frame: after completion of 3 cycles of neoadjuvant chemotherapy (9 weeks after initiation of chemotherapy)). 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 NCT01396655, 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 17 Apr 2025.