Breast NeoplasmsPhase 3NCT01026116
A Randomized Trial Comparing EC-wPversus EP-wP as Adjuvant Therapy for Operable Breast Cancer Patients Less Than 40 Years Old
A Phase 3 study testing Epirubicin, Cyclophosphamide and Paclitaxel in people with Breast Neoplasms, run by Fudan University at 1 site in China.
Trial summary
Manifold data revealed that young breast cancer patients are characterized by aggressive clinical history. The purpose of this study is to evaluate the efficacy and safety of different strategies incorporating paclitaxel to anthracycline-based regimens in young breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Epirubicin, Cyclophosphamide and Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 521 participants
- Where
- 1 siteChina
- Study dates
- Dec 2009to 23 Dec 2016
- Phase
- Phase 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients, age 18~40
- Unilateral, operable, histologically confirmed adenocarcinoma of the breast
- Stage I-III
- Primary surgery with clear margins plus axillary dissection
- Able to start protocol Rx within 8 weeks of surgery
- Histological or cytological confirmation of estrogen-receptor positive (ER+) breast cancer: the immunohistochemical cut-off for ER positive status was
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- 1% or more staining in nuclei
- HER-2 negative (IHC 0,1+ or 2+ with a negative in situ hybridization test by chemotherapy
- pathologically confirmed regional node-positive disease, or node-negative disease with high-risk factors (primary tumor diameter >10 mm when histological grade III, or tumor diameter >20 mm when histological grade II)
- ECOG performance status 0-1
- Adequate cardiac, renal, hepatic and hematologic function
Who cannot join
- Metastatic disease
- Bilateral breast cancer (synchronous or metachronous)
- Prior radiation therapy, hormonal therapy and chemotherapy for breast cancer
- Previous cancer (except treated basal cell and squamous cell carcinoma of the skin or cancer of the uterine cervix)
- HER-2 positive (IHC 3+ OR FISH+) and or triple-negative breast cancer
- Documented history of cardiac disease contradiction anthracyclines
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- Concurrent serious illness
- Peripheral neuropathy of CTC grade>1
- History of hypersensitivity to drugs formulated in Cremophor EL polyoxyethylated castor oil), the vehicle used for commercial paclitaxel formulations
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Breast Surgery, Cancer Hospital, Fudan University
Shanghai, 200032
About this study
Official title: Comparing EC-wP Versus EP-wP as Adjuvant Therapy for Breast Cancer Patients Less Than 40 Years Old
Manifold data revealed that young breast cancer patients are characterized by aggressive clinical history. The purpose of this study is to evaluate the efficacy and safety of different strategies incorporating paclitaxel to anthracycline-based regimens in young breast cancer patients.
- Conditions
- Breast Neoplasms
- Being tested
- Epirubicin, Cyclophosphamide, Paclitaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpirubicinDrug
75 mg/m2 every-3-week for four cycles
CyclophosphamideDrug
600 mg/m2 every-3-week for four cycles
PaclitaxelDrug
175 mg/m2 every-3-week for four cycles followed by weekly paclitaxel (80 mg/m2) for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| EC-wP | Active comparator | epirubicin/cyclophosphamide followed weekly paclitaxel Receives: Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Paclitaxel |
| EP-wP | Experimental | epirubicin/paclitaxel followed by weekly paclitaxel Receives: Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival
Measured: every one year
menstrual resumption rate
Resumption of menses was defined as at least 2 consecutive menstruations, or at least 1 menstruation with a confirmed premenopausal level of FSH and estradiol after chemotherapy
Measured: 12 months after chemotherapy
Secondary outcomes (1)
overall survival
Measured: every one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionJan 2016
- Study completion23 Dec 2016
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 NeoplasmsStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 521 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
- Investigators
- Zhimin Shao, Principal investigator, Cancer Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01026116
- Sponsor's protocol ID
- SHBCC09007
- Status last verified
- May 2020
- First submitted
- 3 Dec 2009
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Yu KD, Ge JY, Liu XY, Mo M, He M, Shao ZM; SPECTRUM Investigators. Cyclophosphamide-Free Adjuvant Chemotherapy for Ovarian Protection in Young Women With Breast Cancer: A Randomized Phase 3 Trial. J Natl Cancer Inst. 2021 Oct 1;113(10):1352-1359. doi: 10.1093/jnci/djab065.
PubMed 33822134
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing EC-wP Versus EP-wP as Adjuvant Therapy for Breast Cancer Patients Less Than 40 Years Old
- ClinicalTrials.gov ID
- NCT01026116
- Acronym / sponsor ID
- SHBCC09007
- Conditions
- Breast Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 521 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jan 2016 (actual)
- Study completion
- 23 Dec 2016 (actual)
- First posted
- 4 Dec 2009 (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.
Manifold data revealed that young breast cancer patients are characterized by aggressive clinical history. The purpose of this study is to evaluate the efficacy and safety of different strategies incorporating paclitaxel to anthracycline-based regimens in young breast cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EC-wP | Active comparator | Drug: Epirubicin, Drug: Cyclophosphamide, Drug: Paclitaxelepirubicin/cyclophosphamide followed weekly paclitaxel |
| EP-wP | Experimental | Drug: Epirubicin, Drug: Cyclophosphamide, Drug: Paclitaxelepirubicin/paclitaxel followed by weekly paclitaxel |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Female patients, age 18~40
- Unilateral, operable, histologically confirmed adenocarcinoma of the breast
- Stage I-III
- Primary surgery with clear margins plus axillary dissection
- Able to start protocol Rx within 8 weeks of surgery
Key exclusion criteria (10 listed)
- Metastatic disease
- Bilateral breast cancer (synchronous or metachronous)
- Prior radiation therapy, hormonal therapy and chemotherapy for breast cancer
- Previous cancer (except treated basal cell and squamous cell carcinoma of the skin or cancer of the uterine cervix)
- HER-2 positive (IHC 3+ OR FISH+) and or triple-negative 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 |
|---|---|---|
| Epirubicin75 mg/m2 every-3-week for four cycles | Drug | EC-wP, EP-wP |
| Cyclophosphamide600 mg/m2 every-3-week for four cycles | Drug | EC-wP, EP-wP |
| Paclitaxel175 mg/m2 every-3-week for four cycles followed by weekly paclitaxel (80 mg/m2) for 12 weeks | Drug | EC-wP, EP-wP |
Primary outcome
disease-free survival
Time frame: every one year
menstrual resumption rate
Time frame: 12 months after chemotherapy
Resumption of menses was defined as at least 2 consecutive menstruations, or at least 1 menstruation with a confirmed premenopausal level of FSH and estradiol after chemotherapy
1 secondary outcome
overall survival
Time frame: every one year
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 12 May 2020.
- Derived from this study: PubMed 33822134Yu KD, Ge JY, Liu XY, Mo M, He M, Shao ZM; SPECTRUM Investigators. Cyclophosphamide-Free Adjuvant Chemotherapy for Ovarian Protection in Young Women With Breast Cancer: A Randomized Phase 3 Trial. J Natl Cancer Inst. 2021 Oct 1;113(10):1352-1359. doi: 10.1093/jnci/djab065.
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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.
Zhimin Shao principal investigator
Cancer Hospital, Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Epirubicin, Cyclophosphamide and Paclitaxel in people with Breast Neoplasms, run by Fudan University at 1 site in China.
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 11 inclusion and 10 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 12 May 2020. 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 China. 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 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?
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?
disease-free survival (time frame: every one year). The study lists 2 primary outcomes in all. 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 NCT01026116, 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 12 May 2020.