A Study for the Neoadjuvant Treatment of Breast Cancer

NCT05420454 | Recruiting Phase 4

• 1 other identifier: 2022-0055
• Study Type: interventional
• Target: 1,576
• Locations: 1 country
• Sites: 1

Brief Summary

Due to the unique advantages of albumin-bound paclitaxel, several studies in China and abroad have tried to use albumin-bound paclitaxel for neoadjuvant treatment of breast cancer up to now. However, comparative studies between paclitaxel and docetaxel are still rare, In this study, a prospective, randomized, open-label, multi-center clinical study was conducted to analyse the efficacy and safety of albumin-bound paclitaxel and docetaxel in the neoadjuvant treatment of breast cancer, and to further analyse the efficacy and safety of albumin paclitaxel in combination with chemotherapy for postoperative breast cancer in different subtypes of breast cancer patients, in order to obtain more realistic data and provide new treatment options for breast cancer patients.

Conditions

Breast Cancer

Keywords

breast cancer; neoadjuvant therapy; Docetaxel; albumin-bound paclitaxel; TCbHP; nPCbHP; ddEC-wnP; EC-T

Outcome Measures

Primary Outcomes (1)

• pCR(pathological complete response)

  defined as ypT0/is, ypN0 (defined as no invasive tumor in breast and axillary lymph nodes

  1year

Secondary Outcomes (4)

• OS

  10 years

• DFS

  2 years

• DMFS

  2 years

• Secondary pCR

  1 year

Other Outcomes (3)

• ORR

  1year

• Remission rate of neurotoxicity

  5 years

• The incidence of other AEs

  5 years

Study Arms (4)

TCbHP

ACTIVE COMPARATOR

HER2-positive breast cancer

Drug: Docetaxel; Drug: Carboplatin; Drug: Trastuzumab; Drug: Pertuzumab

nPCbHP

EXPERIMENTAL

HER2-positive breast cancer

Drug: Carboplatin; Drug: Trastuzumab; Drug: Pertuzumab; Drug: Nab paclitaxel

EC-T

ACTIVE COMPARATOR

Luminal breast cancer (HER2-, LN+), and triple negative breast cancer

Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Docetaxel

ddEC-wnP

EXPERIMENTAL

Luminal breast cancer (HER2-, LN+), and triple negative breast cancer

Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Nab paclitaxel

Interventions

Docetaxel DRUG

75 mg/m2, d1, q3w,6 cycles

TCbHP

Carboplatin DRUG

AUC 6, d1, q3w ,6 cycles

TCbHP; nPCbHP

Trastuzumab DRUG

starting dose 8 mg/kg, maintenance dose 6 mg/kg, d1, q3w ,6 cycles

TCbHP; nPCbHP

Pertuzumab DRUG

starting dose of 840 mg, maintenance dose of 420 mg, d1, q3w,6 cycles

TCbHP; nPCbHP

Nab paclitaxel DRUG

220 mg/m2, d1, q3w,6 cycles

nPCbHP

Epirubicin DRUG

90 mg/m2,d1, q3w × 4 cycles,followed by docetaxel

EC-T

Cyclophosphamide DRUG

600 mg/m2, d1, q3w ,4 cycles,followed by docetaxel

EC-T

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged ≥18 years;
• unilateral primary invasive breast cancer that meets clinical diagnostic criteria and is histologically confirmed;
• The tumor is \>2cm, and the clinical stage is consistent with cT stage 2-4; or lymph node metastasis with clear clinical/pathological evidence;
• known hormone receptor status (estrogen receptor \[ER\], progesterone receptor \[PR\]) and HER2 status with known Ki67 expression levels; (ER/PR positive defined as stained cells \>1%, HER2 positive defined as IHC 3+ or IHC 2+ with a positive FISH test);
• Triple-negative breast cancer (TNBC): ER/PR negative, HER2 negative; tumor \>2cm or lymph node metastasis with clear postoperative pathological evidence; Luminal breast cancer: ER\>1%, HER2 negative, postoperative pathological evidence definite lymph node metastasis (different adjuvant chemotherapy regimens depending on whether the lymph nodes are N1 or N2-3); HER2-positive breast cancer: HER2-positive, regardless of ER/PR status; (the above classification determines enrollment and neoadjuvant therapy, and does not represent the corresponding molecular typing definition);
• patients who need neoadjuvant chemotherapy as judged by the investigator;
• ECOG physical fitness score of 0-1;
• The patient has not received any treatment for breast cancer before enrollment;
• Electrocardiogram (ECG) and echocardiography must confirm normal cardiac function within 3 months prior to randomization. Left ventricular ejection fraction (LVEF) must be ≥55%;
• Liver and kidney function: serum creatinine ≤1.5 times the upper limit of normal; AST and ALT ≤3 times the upper limit of normal; total bilirubin ≤1.5 times the upper limit of normal, or ≤2.5 times the upper limit of normal when the patient has Gilbert's syndrome ;
• Bone marrow function: neutrophils≥1.5×109/L, platelets≥100×109/L, hemoglobin≥90g/L;
• Able to comply with outpatient treatment, laboratory monitoring and necessary clinical visits during the study period;
• Subjects have the ability to understand, agree and sign the Informed Consent Form (ICF) for the study prior to initiating any protocol-related procedures; subjects have the ability to express consent (where applicable).

You may not qualify if:

• Advanced and/or inoperable patients with distant metastasis confirmed by imaging evidence or pathology;
• Patients with bilateral invasive breast cancer;
• Other malignant tumors have occurred in the past 5 years, except for skin cancers of cured cervical carcinoma in situ and non-melanoma;
• Pregnant or breastfeeding women; patients with childbearing potential who are unwilling or unable to take effective contraceptive measures;
• The molecular status of ER/PR and HER2 and Ki67 cannot be determined;
• Patients with CNS metastases or \> grade 1 peripheral neuropathy;
• Surgical axillary staging within 6 months prior to study entry;
• Radiotherapy, chemotherapy, biotherapy and/or endocrine therapy for currently diagnosed breast cancer prior to study entry;
• Patients with severe myelosuppression at screening;
• Patients with severe liver dysfunction (Child's Class III) or renal dysfunction at screening ;
• Other concomitant diseases (e.g. untreated congenital heart disease, glomerulonephritis, etc.) which, in the opinion of the investigator, seriously endanger the safety of the patient or would prevent the implementation or completion of the programme treatment;
• Patients with hypersensitivity to any of the components of albumin paclitaxel, epirubicin, cyclophosphamide, docetaxel, trastuzumab, and pertuzumab;
• Patients with psychiatric disorders;
• Subjects who are participating in another clinical study or whose first dose was administered less than 4 weeks (or 5 half-lives of the study drug) from the end of the previous clinical study (last dose) ;

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (5)

• Robidoux A, Buzdar AU, Quinaux E, Jacobs S, Rastogi P, Fourchotte V, Younan RJ, Pajon ER, Shalaby IA, Desai AM, Fehrenbacher L, Geyer CE Jr, Mamounas EP, Wolmark N. A phase II neoadjuvant trial of sequential nanoparticle albumin-bound paclitaxel followed by 5-fluorouracil/epirubicin/cyclophosphamide in locally advanced breast cancer. Clin Breast Cancer. 2010 Feb;10(1):81-6. doi: 10.3816/CBC.2010.n.011.

  PMID: 20133263 BACKGROUND

• Shimada H, Ueda S, Saeki T, Shigekawa T, Takeuchi H, Hirokawa E, Sugitani I, Sugiyama M, Takahashi T, Matsuura K, Yamane T, Kuji I, Hasebe T, Osaki A. Neoadjuvant triweekly nanoparticle albumin-bound paclitaxel followed by epirubicin and cyclophosphamide for Stage II/III HER2-negative breast cancer: evaluation of efficacy and safety. Jpn J Clin Oncol. 2015 Jul;45(7):642-9. doi: 10.1093/jjco/hyv055. Epub 2015 May 19.

  PMID: 25989989 BACKGROUND

• Untch M, Jackisch C, Schneeweiss A, Conrad B, Aktas B, Denkert C, Eidtmann H, Wiebringhaus H, Kummel S, Hilfrich J, Warm M, Paepke S, Just M, Hanusch C, Hackmann J, Blohmer JU, Clemens M, Darb-Esfahani S, Schmitt WD, Dan Costa S, Gerber B, Engels K, Nekljudova V, Loibl S, von Minckwitz G; German Breast Group (GBG); Arbeitsgemeinschaft Gynakologische Onkologie-Breast (AGO-B) Investigators. Nab-paclitaxel versus solvent-based paclitaxel in neoadjuvant chemotherapy for early breast cancer (GeparSepto-GBG 69): a randomised, phase 3 trial. Lancet Oncol. 2016 Mar;17(3):345-356. doi: 10.1016/S1470-2045(15)00542-2. Epub 2016 Feb 8.

  PMID: 26869049 BACKGROUND

• Untch M, Jackisch C, Schneeweiss A, Schmatloch S, Aktas B, Denkert C, Schem C, Wiebringhaus H, Kummel S, Warm M, Fasching PA, Just M, Hanusch C, Hackmann J, Blohmer JU, Rhiem K, Schmitt WD, Furlanetto J, Gerber B, Huober J, Nekljudova V, von Minckwitz G, Loibl S. NAB-Paclitaxel Improves Disease-Free Survival in Early Breast Cancer: GBG 69-GeparSepto. J Clin Oncol. 2019 Sep 1;37(25):2226-2234. doi: 10.1200/JCO.18.01842. Epub 2019 May 13.

  PMID: 31082269 BACKGROUND

• Kuwayama T, Nakamura S, Hayashi N, Takano T, Tsugawa K, Sato T, Kitani A, Okuyama H, Yamauchi H. Randomized Multicenter Phase II Trial of Neoadjuvant Therapy Comparing Weekly Nab-paclitaxel Followed by FEC With Docetaxel Followed by FEC in HER2- Early-stage Breast Cancer. Clin Breast Cancer. 2018 Dec;18(6):474-480. doi: 10.1016/j.clbc.2018.06.012. Epub 2018 Jun 27.

  PMID: 30072191 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Carboplatin; Trastuzumab; pertuzumab; Taxes; Epirubicin; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Economics; Health Care Economics and Organizations; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Central Study Contacts

Yiding CHEN

CONTACT

13605719519; ydchen@zju.edu.cn

Huihui CHEN

CONTACT

571-87784527; huihuicyj@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2022
• First Posted: June 15, 2022
• Study Start: July 10, 2022
• Primary Completion (Estimated): June 10, 2027
• Study Completion (Estimated): December 20, 2027
• Last Updated: July 1, 2022

Record last verified: 2022-06

Locations

CN (1)