Tubular Breast CancerPhase 2SHPD001NCT02199418
Addition of Cisplatin to Neoadjuvant Therapy for T Locally Advanced Breast Cancer
A Phase 2 study testing Paclitaxel and Cisplatin in people with Tubular Breast Cancer and Mucinous Breast Cancer, run by RenJi Hospital at 2 sites in China.
Trial summary
The investigators hypotheses that paclitaxel combined with cisplatin in a weekly-based regimen as neoadjuvant chemotherapy is effective and tolerable for locally advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Tubular Breast Cancer, Mucinous Breast Cancer, Invasive Ductal Breast Cancer
- What is being tested?
- Paclitaxel and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 2 sitesChina
- Study dates
- Jan 2013to Oct 2016
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged ≥18years and ≤70 years
- At least on measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST). Histologically confirmed invasive breast cancer, tumor size ≥2 cm, T2-4 N0-2M0
- ER/PR/HER-2 and Ki-67 status detected on core biopsy. ER/PR positive is defined as >1% stained cells and HER2-positive is defined as immuno-histochemistry (IHC) 3+ or FISH ratio ≥ 2.0
- No prior systemic or loco-regional treatment of breast cancer
- ECOG 0-2
- Adequate bone marrow function:WBC≥4.0×109/L, Absolute neutrophil count（ANC）≥1.5×109/L, Platelets（PLT）≥100×109/L, Hemoglobin（Hb）≥90g/L;aspartate aminotransferase(AST),Alanine aminotransferase (ALT)≤1.5 upper normal limit （UNL）, creatinine≤1.5 UNL, bilirubin≤1.5UNL
- No obvious main organs dysfunction
Who cannot join
- Unwilling or unable to use an acceptable method of contraception in 8 weeks (including 8 weeks) after final dose of test drug
- Patient is pregnant or breast feeding
- Inflammatory breast cancer and metastatic breast cancer
- Any evidence of sense or motor nerve disorders
- Patients with medical conditions taht indicate intolerant to neoadjuvant therapy, including uncontrolled cardiovascular disease, severe infection
- Any concurrent malignancy other than breast cancer
- Know severe hypersensitivity to any drugs in this study
Trial locations and contacts
2 sites in 1 country.
China2 sites
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Shanghai Jiaotong University School of Medicine, Renji Hospital
Shanghai, Shanghai Municipality, 200127
About this study
Official title: Phase 2 Study of Weekly Paclitaxel in Combination With Cisplatin as Neoadjuvant Therapy for Locally Advanced Breast Cancer Patients
The investigators hypotheses that paclitaxel combined with cisplatin in a weekly-based regimen as neoadjuvant chemotherapy is effective and tolerable for locally advanced breast cancer.
Read the detailed description
In this trial, all the patients will have weekly paclitaxel and cisplatin as neoadjuvant chemotherapy for 4 cycles. Patients with Her2 positive tumor will also receive the trastuzumab.
- Conditions
- Tubular Breast Cancer, Mucinous Breast Cancer, Invasive Ductal Breast Cancer, Inflammatory Breast Cancer
- Being tested
- Paclitaxel, Cisplatin
- Medical subject headings
- Carcinoma, Ductal, Breast, Inflammatory Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called Taxol
CisplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel and Cisplatin | Experimental | Paclitaxel: 80 mg/m² i.v. given weekly on day 1 q day 8 for 16 weeks. Cisplatin: 25 mg/m² weekly on day 1 ,8,and 15 q day 28 for 4 cycles.
Trastuzumab (only for human epidermal growth factor receptor-2(HER2)-positive patients): Loading dose: 4 mg/kg, Maintenance dose: 2 mg/kg, day 1 q day 8 for 16 weeks. Post-surgery: up to a total duration of 1 year Receives: Drug: Paclitaxel; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response of breast and lymph nodes
Measured: after 4 months preoperative treatment
Secondary outcomes (6)
Tolerability and Safety
Descriptive statistics for the treatment will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped
Measured: 4 months during neoadjuvant therapy
Clinical and imaging response
To determine the response rates of the breast tumor and axillary nodes based on physical examination and imaging tests. (sonography, mammography, or MRI) after treatment
Measured: 4 months during treatment
regional recurrence free survival (RRFS)
RRFS is defined as the time period between registration and first event
Measured: 5 years
local recurrence free survival (LRFS)
LRFS is defined as the time period between registration and first event
Measured: 5 years
distant-disease- free survival (DDFS)
DFS is defined as the time period between registration and first event
Measured: 5 years
overall survival (OS)
OS is defined as the time period between registration and first event
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 posted24 Jul 2014 (estimated)
- Study startJan 2013
- Primary completionNov 2015
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tubular Breast CancerStudies of the same condition, open and under way.
- More trials run by RenJi 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
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinsong Lu, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02199418
- Sponsor's protocol ID
- RenJiH-BC-001
- Acronym
- SHPD001
- Status last verified
- Jan 2017
- First submitted
- 14 Jul 2014
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wan C, Zhou L, Jin Y, Li F, Wang L, Yin W, Wang Y, Li H, Jiang L, Lu J. Strain ultrasonic elastography imaging features of locally advanced breast cancer: association with response to neoadjuvant chemotherapy and recurrence-free survival. BMC Med Imaging. 2023 Dec 21;23(1):216. doi: 10.1186/s12880-023-01168-2.
PubMed 38129778Sun L, Yin W, Wu Z, Wang Y, Lu J. The Predictive Value of Pre-therapeutic Serum Gamma-glutamyl transferase in Efficacy and Adverse Reactions to Neoadjuvant Chemotherapy among Breast Cancer Patients. J Breast Cancer. 2020 Oct;23(5):509-520. doi: 10.4048/jbc.2020.23.e59.
PubMed 33154826Wu Z, Zhang L, Xu S, Lin Y, Yin W, Lu J, Sha R, Sheng X, Zhou L, Lu J. Predictive and prognostic value of ZEB1 protein expression in breast cancer patients with neoadjuvant chemotherapy. Cancer Cell Int. 2019 Mar 29;19:78. doi: 10.1186/s12935-019-0793-2. eCollection 2019.
PubMed 30976202
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Weekly Paclitaxel in Combination With Cisplatin as Neoadjuvant Therapy for Locally Advanced Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT02199418
- Acronym / sponsor ID
- SHPD001 / RenJiH-BC-001
- Conditions
- Tubular Breast Cancer, Mucinous Breast Cancer, Invasive Ductal Breast Cancer, Inflammatory Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 24 Jul 2014 (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 investigators hypotheses that paclitaxel combined with cisplatin in a weekly-based regimen as neoadjuvant chemotherapy is effective and tolerable for locally advanced breast cancer.
Detailed description
In this trial, all the patients will have weekly paclitaxel and cisplatin as neoadjuvant chemotherapy for 4 cycles. Patients with Her2 positive tumor will also receive the trastuzumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel and Cisplatin | Experimental | Drug: Paclitaxel, Drug: CisplatinPaclitaxel: 80 mg/m² i.v. given weekly on day 1 q day 8 for 16 weeks. Cisplatin: 25 mg/m² weekly on day 1 ,8,and 15 q day 28 for 4 cycles. Trastuzumab (only for human epidermal growth factor receptor-2(HER2)-positive patients): Loading dose: 4 mg/kg, Maintenance dose: 2 mg/kg, day 1 q day 8 for 16 weeks. Post-surgery: up to a total duration of 1 year |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women aged ≥18years and ≤70 years
- At least on measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST). Histologically confirmed invasive breast cancer, tumor size ≥2 cm, T2-4 N0-2M0
- ER/PR/HER-2 and Ki-67 status detected on core biopsy. ER/PR positive is defined as >1% stained cells and HER2-positive is defined as immuno-histochemistry (IHC) 3+ or FISH ratio ≥ 2.0
- No prior systemic or loco-regional treatment of breast cancer
- ECOG 0-2
Key exclusion criteria (7 listed)
- Unwilling or unable to use an acceptable method of contraception in 8 weeks (including 8 weeks) after final dose of test drug
- Patient is pregnant or breast feeding
- Inflammatory breast cancer and metastatic breast cancer
- Any evidence of sense or motor nerve disorders
- Patients with medical conditions taht indicate intolerant to neoadjuvant therapy, including uncontrolled cardiovascular disease, severe infection
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 |
|---|---|---|
| PaclitaxelAlso: Taxol | Drug | Paclitaxel and Cisplatin |
| Cisplatin | Drug | Paclitaxel and Cisplatin |
Primary outcome
Pathological complete response of breast and lymph nodes
Time frame: after 4 months preoperative treatment
6 secondary outcomes
Tolerability and Safety
Time frame: 4 months during neoadjuvant therapy
Clinical and imaging response
Time frame: 4 months during treatment
regional recurrence free survival (RRFS)
Time frame: 5 years
local recurrence free survival (LRFS)
Time frame: 5 years
distant-disease- free survival (DDFS)
Time frame: 5 years
overall survival (OS)
Time frame: 5 years
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 25 Jan 2017.
- Derived from this study: PubMed 38129778Wan C, Zhou L, Jin Y, Li F, Wang L, Yin W, Wang Y, Li H, Jiang L, Lu J. Strain ultrasonic elastography imaging features of locally advanced breast cancer: association with response to neoadjuvant chemotherapy and recurrence-free survival. BMC Med Imaging. 2023 Dec 21;23(1):216. doi: 10.1186/s12880-023-01168-2.
- Derived from this study: PubMed 33154826Sun L, Yin W, Wu Z, Wang Y, Lu J. The Predictive Value of Pre-therapeutic Serum Gamma-glutamyl transferase in Efficacy and Adverse Reactions to Neoadjuvant Chemotherapy among Breast Cancer Patients. J Breast Cancer. 2020 Oct;23(5):509-520. doi: 10.4048/jbc.2020.23.e59.
- Derived from this study: PubMed 30976202Wu Z, Zhang L, Xu S, Lin Y, Yin W, Lu J, Sha R, Sheng X, Zhou L, Lu J. Predictive and prognostic value of ZEB1 protein expression in breast cancer patients with neoadjuvant chemotherapy. Cancer Cell Int. 2019 Mar 29;19:78. doi: 10.1186/s12935-019-0793-2. eCollection 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel and Cisplatin in people with Tubular Breast Cancer and Mucinous Breast Cancer, run by RenJi Hospital at 2 sites 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 7 inclusion and 7 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 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
Pathological complete response of breast and lymph nodes (time frame: after 4 months preoperative treatment). 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 NCT02199418, which also lists 3 linked publications.
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 25 Jan 2017.