ClinicalTrials.Veeva

Menu

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

S

Shandong First Medical University

Status and phase

Unknown
Phase 3

Conditions

Breast Cancer

Treatments

Device: Pathologic Large Tissue Embedded Table
Drug: TAC,TC,TA,CAF,CEF
Procedure: HE Stain
Device: Mammography
Procedure: Three-Dimensional Reconstruction
Device: Epson V600
Drug: AC-P,TEC,AC,TC,TCH,CEF,TAC,CAF
Device: Ultrasound
Device: Leica SM2000 R
Procedure: BCS, Modified Radical Mastectomy
Device: Pathologic Large Tissue Selected Table
Device: Leica TP1020
Device: CX22
Device: MRI
Procedure: CNB

Study type

Interventional

Funder types

Other

Identifiers

NCT01917578
BCSMANC001

Details and patient eligibility

About

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.

Enrollment

4 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Female patients,locally advanced breast cancer,age ≥18 years.

  2. Histologically confirmed invasive adenocarcinoma of the breast.

  3. 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.)

  4. 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.

  5. ECOG 0 or 2

  6. No distant metastasis, as documented by complete staging workup ≤6 weeks prior to initiation of study treatment.

  7. No previous treatment for breast cancer.

  8. Adequate hematologic function with:

    Absolute neutrophil count (ANC) >1500/μL. Platelets ≥100,000/μL. Hemoglobin ≥10 g/dL.

  9. 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.

  10. Adequate renal function with serum creatinine ≤1.5 x ULN.

  11. Planned primary systemic (neoadjuvant) chemotherapy and surgical resection of residual primary tumor (mastectomy or lumpectomy/breast conservation) following completion of neoadjuvant chemotherapy

Exclusion criteria

  1. inflammatory breast cancer
  2. 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.
  3. 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.
  4. Uncontrolled intercurrent illness including (but not limited to) ongoing or active infection.
  5. Concurrent treatment with any anti-cancer therapy other than those agents used in this study.
  6. 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 design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

4 participants in 2 patient groups

Half Cycles Group
Experimental group
Description:
Patients complete half of the whole cycles of neoadjuvant chemotherapy.
Treatment:
Drug: TAC,TC,TA,CAF,CEF
Procedure: CNB
Device: Pathologic Large Tissue Embedded Table
Device: Leica TP1020
Procedure: HE Stain
Device: CX22
Device: Epson V600
Device: Leica SM2000 R
Procedure: BCS, Modified Radical Mastectomy
Device: Mammography
Device: Ultrasound
Procedure: Three-Dimensional Reconstruction
Device: Pathologic Large Tissue Selected Table
Whole Cycles Group
Experimental group
Description:
Patients complete whole cycles of neoadjuvant chemotherapy.
Treatment:
Procedure: CNB
Device: Pathologic Large Tissue Embedded Table
Device: Leica TP1020
Procedure: HE Stain
Device: CX22
Device: Epson V600
Drug: AC-P,TEC,AC,TC,TCH,CEF,TAC,CAF
Device: Leica SM2000 R
Procedure: BCS, Modified Radical Mastectomy
Device: Mammography
Device: Ultrasound
Procedure: Three-Dimensional Reconstruction
Device: Pathologic Large Tissue Selected Table
Device: MRI

Trial contacts and locations

1

Loading...

Central trial contact

Yong-sheng Wang, MD; Tao Yang, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems