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Breast CancerPhase 3BCSMANCNCT01917578

Study of Breast Cancer Shrinkage Modes After Neoadjuvant Chemotherapy With Whole-mount Serial Sections and Three-dimensional Pathological and MRI Reconstruction

A Phase 3 study testing Ultrasound, CNB and BCS, Modified Radical Mastectomy in people with Breast Cancer, run by Shandong Cancer Hospital and Institute at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The main clinical goal of NAC is to down-stage the primary tumor for BCS,yet BCS after NAC has been associated with significantly higher ipsilateral breast tumor recurrences.The accuracy of breast tumor excision in BCS can dramatically reduce IBTR.The main reseason of IBTR might be the uncertain shrinkage modes of the… Read more about this study

Who is it for?
Ages 18 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer
What is being tested?
Ultrasound, CNB and BCS, Modified Radical Mastectomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteChina
Study dates
Aug 2008to Jul 2014
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 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Female patients,locally advanced breast cancer,age ≥18 years.
  • Histologically confirmed invasive adenocarcinoma of the breast.
  • Primary palpable disease confined to a breast and axilla on physical examination. For patients without clinically suspicious axillary adenopathy, the primary tumor must be larger than 2 cm in diameter by physical exam or imaging studies (clinical T2-T3, N0-N1, M0). For patients with clinically suspicious axillary adenopathy, the primary breast tumor can be any size (clinical T1-3, N1-2, M0). (T1N0M0 lesions are excluded.)
  • Patients without clearly defined palpable breast mass or axillary lymph nodes but radiographically measurable tumor masses are acceptable. Accepted procedures for measuring breast disease are mammography, MRI, and breast ultrasound. This will need to be re-evaluated after 3 cycles and prior to surgery.
  • ECOG 0 or 2
  • No distant metastasis, as documented by complete staging workup ≤6 weeks prior to initiation of study treatment.
Show all 13Show fewer
  • No previous treatment for breast cancer.
  • Adequate hematologic function with:
  • Absolute neutrophil count (ANC) >1500/μL. Platelets ≥100,000/μL. Hemoglobin ≥10 g/dL.
  • Adequate hepatic function with:
  • Serum bilirubin ≤ the institutional upper limit of normal (ULN). Aspartate aminotransferase (AST) ≤2.5 x institutional ULN. Alanine aminotransferase (ALT) ≤2.5 x institutional ULN.
  • Adequate renal function with serum creatinine ≤1.5 x ULN.
  • Planned primary systemic (neoadjuvant) chemotherapy and surgical resection of residual primary tumor (mastectomy or lumpectomy/breast conservation) following completion of neoadjuvant chemotherapy

Who cannot join

  • inflammatory breast cancer
  • Pregnancy or breast-feeding.A negative serum pregnancy test within 7 days prior to first study treatment (Day 1, Cycle 1) for all women of childbearing potential is required. Patients of childbearing potential must agree to use a birth control method that is approved by their study physician while receiving study treatment and for 3 weeks after their last dose of study treatment. Patients must agree to not breast-feed while receiving study treatment.
  • Concurrent treatment with an ovarian hormonal replacement therapy or with hormonal agents such as raloxifene, tamoxifen or other selective estrogen receptor modulator (SERM). Patients must have discontinued use of such agents prior to beginning study treatment.
  • Uncontrolled intercurrent illness including (but not limited to) ongoing or active infection.
  • Concurrent treatment with any anti-cancer therapy other than those agents used in this study.
  • Mental condition or psychiatric disorder that would prevent patient comprehension of the nature, scope, and possible consequences of the study or that would limit compliance with study requirements.

Trial locations and contacts

1 site in 1 country.

Yong-sheng Wang, MD contact

+8613505409989

wangysh2008@aliyun.com

Tao Yang, MD contact

+8618264190568

yangtao133252@aliyun.com

China1 site, 1 recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

    Yong-sheng Wang, MD, +8613505409989, wangysh2008@aliyun.com

    Tao Yang, MD, +8618264190568, yangtao133252@aliyun.com

    Recruiting

Other trials in China

About this study

Official title: Phase III Trail of Breast Cancer Shrinkage Modes After Neoadjuvant Chemotherapy With Whole-mount Serial Sections and Three-dimensional Pathological and MRI Reconstruction

The main clinical goal of NAC is to down-stage the primary tumor for BCS,yet BCS after NAC has been associated with significantly higher ipsilateral breast tumor recurrences.The accuracy of breast tumor excision in BCS can dramatically reduce IBTR.The main reseason of IBTR might be the uncertain shrinkage modes of the breast cancer after NAC.This clinical trial is firstly carried out to make clear the shrinkage modes of the primary tumor after 3 cycles and whole cycles of NAC,respectively,with whole-mount serial section(WMSS) and three-dimensional(3D) pathological reconstruction of the residual tumor.The second objective is to investigate the predictive value of 3D MRI reconstruction for the shrinkage modes of the primary tumor after NAC.

Conditions
Breast Cancer
Being tested
Ultrasound, CNB, BCS, Modified Radical Mastectomy, Pathologic Large Tissue Selected Table, Leica TP1020
Keywords
Breast Cancer, shrinkage modes, three-dimensional reconstruction, neoadjuvant chemotherapy, Magnetic Resonance Imaging
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UltrasoundDevice

    Also called GE LOGIQ C5

    1. Evaluation of the tumor size by sonography is performed before neoadjuvant chemotherapy and prior to surgery.
    2. Measurement of tumor size refers to WHO standards.

  • CNBProcedure or surgery

    Also called core needle biopsy

    Typically, the pretreatment tumor specimen will be a core needle biopsy. Because 15% to 28% of patients will have no residual tumor after NAT, it is important to have an adequate pretreatment sample in which an unequivocal diagnosis of invasive carcinoma is established and evaluation of hormone receptors and HER2/ neu status is completed before treatment.

  • BCS, Modified Radical MastectomyProcedure or surgery

    Also called BCS: breast conservative surgery

    All patients after neoadjuvant chemotherapy are performed BCS and modified radical mastectomy.

  • Pathologic Large Tissue Selected TableDevice

    1. Pathologic large tissue selected table has obtained Chinese patent.Its license ID is CN101261200.
    2. Each piece of breast tissues by cutting with the table has 3mm thickness.

  • Leica TP1020Device

    Also called Semi-enclosed Benchtop Tissue Processor Leica TP1020

    Procedure:

    1. Alcohol 70 % 1h
    2. Alcohol 80 % 1h
    3. Alcohol 85 % 1h
    4. Alcohol 90 % 1h
    5. Alcohol 95 % 1h
    6. Alcohol Ⅰ 100 % 1h
    7. Alcohol Ⅱ 100 % 1h
    8. Xylene Ⅰ 2h
    9. Xylene Ⅱ 2h
    10. Xylene Ⅲ 2h
    11. Paraffin 6h
    12. Paraffin 6h

  • Pathologic Large Tissue Embedded TableDevice

    1. The table is made of brass .It is applying for a chinese patent.
    2. The table can simultaneously embed 8 piece of breast tissues.

  • Leica SM2000 RDevice

    Also called Sliding microtome Leica SM2000 R

    Each of paraffin section has 4 um thickness.

  • HE StainProcedure or surgery

    Procedure:

    1. Xylene Ⅰ 60℃ 15-20 minutes
    2. Xylene Ⅱ 60℃ 15-20 minutes
    3. Alcohol 100% Ⅰ 3-5 minutes
    4. Alcohol 100% Ⅱ 3-5 minutes
    5. Alcohol 95% Ⅱ 3-5 minutes
    6. Alcohol 90% Ⅱ 3-5 minutes
    7. Wash in running tap water for 3 minutes
    8. Hematoxylin 5-10 minutes
    9. Wash in running tap water for 3 minutes
    10. Differentiate in 1% acid alcohol for 30 seconds
    11. Wash in running tap water for 1 minute
    12. Bluing in 0.2% ammonia water for 30-60 seconds
    13. Wash in running tap water for 3 minutes
    14. Counterstain in eosin Y solution for 30-60 seconds
    15. Wash in running tap water for 1 minute
    16. Alcohol 90% Ⅱ 2-3 minutes
    17. Alcohol 95% Ⅱ 2-3 minutes
    18. Alcohol 100% Ⅱ 3-5 minutes
    19. Alcohol 100% Ⅱ 3-5 minutes
    20. Xylene Ⅲ 5-10 minutes
    21. Xylene Ⅳ 5-10 minutes
    22. Mounting with neutral resin

  • CX22Device

    Also called Biological Microscope CX22（Olympus）

    The residual tumor areas are microscopically outlined on each slice by pathologist.

  • Epson V600Device

    Also called Epson Perfection V600 Photo Scanner

    1. Each slice that has been microscopically outlined is scanned by Epson V600.
    2. Every image by scanning should be saved as JPG.

  • MRIDevice

    Also called Philips Achieva 3.0T MRI System

    1. Evaluation of the tumor size by MRI was performed before neoadjuvant chemotherapy and prior to surgery.
    2. Measurement of tumor size refers to WHO standards.
    3. The images of patients which were scanned by MRI should be burned onto disc for 3d reconstruction.

  • Three-Dimensional ReconstructionProcedure or surgery

    A.Pathological images three-dimensional reconstruction:

    1. Pathological images registration is based on skin and shear mark by Photoshop 13.0 software.
    2. Residual tumor boundary on Pathological images after registration are outlined and taken three-dimensional reconstruction by 3D-doctor 4.0 software.
    3. Observe the shrinkage modes in three-dimensional space.
    4. According to WHO standard,the boundaries of all residual tumor images are displayed in one plane and the longest diameter and its longest perpendicular diameter of boundaries are measured in one-dimensional space.
    5. According to RECIST standard,the longest diameter of boundaries of residual tumor images in three-dimensional space.

    B.MRI images three-dimensional reconstruction:the procedure is similar to Pathological images three-dimensional reconstruction

  • MammographyDevice

    Also called GE Mammography

    1. Evaluation of the tumor size by mammography is performed before neoadjuvant chemotherapy and prior to surgery.
    2. Measurement of tumor size and calcification extent refers to WHO standards.
    3. Calcification extent is not only measured in mammography image but also under microscope.

  • TAC,TC,TA,CAF,CEFDrug

    Also called 1.TAC(docetaxel/doxorubicin/cyclophosphamide), 2.TC(docetaxel/cyclophosphamide), 3.TA(paclitaxel/doxorubicin), 4.CAF(fluorouracil/doxorubicin/cyclophosphamide)

    1. TAC:Docetaxel 75 mg/㎡ iv day 1 + Doxorubicin 50 mg/㎡ in day 1 + Cyclophosphamide 500 mg/㎡ iv day 1(Cycled every 21 days for 3 cycles)
    2. TC:Docetaxel 75 mg/㎡ iv day 1 + Cyclophosphamide 600 mg/㎡in day 1(Cycled every 21 days for 2 cycles)
    3. TA:Docetaxel 75 mg/㎡ iv day 1 + Doxorubicin 50 mg/㎡ in day 1(Cycled every 21 days for 2 cycles)
    4. CAF:Cyclophosphamide 100 mg/㎡ po days 1-14 + Doxorubicin 30 mg/㎡ iv days 1,8 +5-fluorouracil 500 mg/㎡ iv days 1,8(cycled every 28 days for 3 cycles)
    5. CEF:Cyclophosphamide 75 mg/㎡ po day 1-14 + Epirubicin 60 mg/㎡ iv days 1,8 + 5-fluorouracil 500mg/㎡ iv days 1,8(cycled every 28 days for 3 cycles)

  • AC-P,TEC,AC,TC,TCH,CEF,TAC,CAFDrug

    Also called 1.AC(doxorubicin/cyclophosphamide)-P(paclitaxel), 2.TEC(docetaxel/epirubicin/cyclophosphamide), 3.AC(doxorubicin/cyclophosphamide)-T(docetaxel), 4.TC(docetaxel/cyclophosphamide)

    1. AC-P:Doxorubicin 60 mg/㎡ iv day 1 +Cyclophosphamide 600 mg/㎡ iv day 1(Cycled every 14 days for 4 cycles)→ Paclitaxel 175mg/㎡ by 3h iv infusion day 1(Cycled every 14 days for 4 cycles) or Paclitaxel 80mg/㎡ by 1h iv infusion weekly for 12 wks.
    2. TEC:Docetaxel 75 mg/㎡ iv day 1 + Epirubicin 75 mg/㎡ in day 1 + Cyclophosphamide 500 mg/㎡ iv day 1(Cycled every 21 days for 6 cycles)
    3. AC:Doxorubicin 60 mg/㎡ in day 1 + Cyclophosphamide 600 mg/㎡ iv day 1(Cycled every 21 days for 4 cycles)
    4. TC:Docetaxel 75 mg/㎡ iv day 1 + Cyclophosphamide 600 mg/㎡in day 1(Cycled every 21 days for 4 cycles)
    5. TCH:Docetaxel 75 mg/㎡ iv day 1 + Carboplatin AUC 6 iv day1(Cycled every 21 days for 6 cycles) + Trastuzumab 4 mg/kg iv wk 1 → Trastuzumab 2 mg/kg iv for 17 wks → Trastuzumab 6 mg/kg iv every 3 wks to complete 1 year.
    6. CEF:Cyclophosphamide 75 mg/㎡ po day 1-14 + Epirubicin 60 mg/㎡ iv days 1,8 + 5-fluorouracil 500mg/㎡ iv days 1,8(cycled every 28 days for 6 cycles)
Study groups in NCT01917578
Study groupRoleWhat they receive
Half Cycles GroupExperimentalPatients complete half of the whole cycles of neoadjuvant chemotherapy.
Receives: Device: Ultrasound; Procedure: CNB; Procedure: BCS, Modified Radical Mastectomy; Device: Pathologic Large Tissue Selected Table; Device: Leica TP1020; Device: Pathologic Large Tissue Embedded Table; Device: Leica SM2000 R; Procedure: HE Stain; Device: CX22; Device: Epson V600; Procedure: Three-Dimensional Reconstruction; Device: Mammography; Drug: TAC,TC,TA,CAF,CEF
Whole Cycles GroupExperimentalPatients complete whole cycles of neoadjuvant chemotherapy.
Receives: Device: Ultrasound; Procedure: CNB; Procedure: BCS, Modified Radical Mastectomy; Device: Pathologic Large Tissue Selected Table; Device: Leica TP1020; Device: Pathologic Large Tissue Embedded Table; Device: Leica SM2000 R; Procedure: HE Stain; Device: CX22; Device: Epson V600; Device: MRI; Procedure: Three-Dimensional Reconstruction; Device: Mammography; Drug: AC-P,TEC,AC,TC,TCH,CEF,TAC,CAF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The shrinkage modes of breast tumor after NAC.

    The tumor shrinkage modes of the primary tumor in patients with locally advanced breast cancer after 3 cycles and whole cycles of neoadjuvant chemotherapy(NAC).

    Measured: 6 year

Secondary outcomes (1)

  1. The WMSS and 3D pathological reconstruction of the residual tumors after NAC.

    The whole-mount serial section(WMSS) and three-dimensional(3D) pathological reconstruction of the residual tumors after NAC.

    Measured: 6 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2013 (estimated)
  2. Study startAug 2008
  3. Primary completionMar 2014 (estimated)
  4. Study completionJul 2014 (estimated)

Resources

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
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01917578
Sponsor's protocol ID
BCSMANC001
Acronym
BCSMANC
Status last verified
Aug 2013
First submitted
4 Aug 2013
Last updated
6 Aug 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Y-S Wang, Z-P Zhang, G Liu, D-B Mu, and X-Y Sun.Study of Breast Cancer Shrinkage Modes After Neoadjuvant Chemotherapy With Whole-mount Serial Sections and Three-dimensional Pathological and MRI Reconstruction. Cancer Res 2012;72(24 Suppl):Abstract nr P1-14-17.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ultrasound, CNB and BCS, Modified Radical Mastectomy in people with Breast Cancer, run by Shandong Cancer Hospital and Institute 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 13 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: status not confirmed, as of the sponsor's last update on 6 Aug 2013. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yong-sheng Wang, MD (+8613505409989, wangysh2008@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The shrinkage modes of breast tumor after NAC. (time frame: 6 year). 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 NCT01917578, 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 6 Aug 2013.

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