A Study for the Adjuvant Treatment of Breast Cancer

NCT05420467 | Recruiting Phase 4

• 1 other identifier: 2022-0056
• Study Type: interventional
• Target: 2,413
• Locations: 1 country
• Sites: 1

Brief Summary

Studies on postoperative adjuvant albumin paclitaxel in domestic breast cancer patients are less reported, especially in large samples, and more studies focus more on the safety and tolerability of albumin paclitaxel use. Head-to-head studies of white violet and docetaxel are not supported by data at this time, but some studies have shown that docetaxel-induced long-term Other adverse effects such as myelosuppression, hepatotoxicity and hypersensitivity reactions can have a serious impact on quality of life. Therefore, this study aims to analyse the efficacy and safety of albumin paclitaxel and docetaxel in the adjuvant treatment of breast cancer in a large randomized controlled trial, 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; adjuvant therapy; Docetaxel; albumin paclitaxel; TCbHP; nPCbHP; ddEC-wnP; TC; nPC; EC-T

Outcome Measures

Primary Outcomes (1)

• 5-year DFS

  5-year disease-free survival

  5-years

Other Outcomes (5)

• DMFS

  2 years

• OS

  10 years

• RFS

  2 years

Study Arms (6)

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-, more than 4 lymph node metastases), and triple negative breast cancer

Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Docetaxel

ddEC-wnP

EXPERIMENTAL

Luminal breast cancer (HER2-, more than 4 lymph node metastases), and triple negative breast cancer

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

TC

ACTIVE COMPARATOR

Luminal breast cancer (HER2-, with 1-3 lymph nodes)

Drug: Docetaxel; Drug: Cyclophosphamide

nPC

EXPERIMENTAL

Luminal breast cancer (HER2-, with 1-3 lymph nodes)

Drug: Nab paclitaxel; Drug: Cyclophosphamide

Interventions

Docetaxel DRUG

75 mg/m2, d1, q3w,6 cycles

TC; 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

nPC; 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;
• Histopathologically or cytologically confirmed breast cancer patients with the following characteristics:1. stage I to III breast cancer; 2. operable primary lesion with no evidence of distant metastasis (M0);
• 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 adjuvant therapy, and does not represent the corresponding molecular typing definition);
• Patients who have undergone breast cancer resection and systemic intrathoracic lymph node dissection; surgical resection is R0 resection; patients who need postoperative adjuvant chemotherapy as judged by the investigator;
• Start of adjuvant therapy within 21 days of the time of surgery is appropriate ;
• ECOG physical fitness score of 0-1 with an expected survival of \>6 months ;
• Patients have not been treated with a paclitaxel regimen prior to enrolment ;
• Adjuvant chemotherapy should not be performed concurrently with endocrine therapy drugs such as tamoxifen/aromatase inhibitors or postoperative radiotherapy;
• Women of childbearing age must have taken reliable contraceptive measures, or performed a pregnancy test (serum or urine) within 7 days before enrollment, with a negative result, and be willing to use appropriate contraceptives during the trial and 8 weeks after the last dose of the trial drug;
• Electrocardiogram (ECG) and echocardiography must confirm normal cardiac function within 3 months prior to randomization. Left ventricular ejection fraction (LVEF) must be ≥55% for patients receiving anthracycline-containing chemotherapy regimens and targeted therapy ;
• 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 (if applicable).

You may not qualify if:

• Advanced and/or inoperable patients with distant metastasis confirmed by imaging evidence or pathology;
• 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;
• Severe cardiovascular disease: Grade II or higher myocardial ischaemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥ 470 ms); Grade III-IV cardiac insufficiency according to NYHA criteria, or cardiac ultrasound indicating a left ventricular ejection fraction (LVEF) of \<50%;
• Patients with hypertension that cannot be reduced to the normal range after antihypertensive medication (systolic blood pressure\>140 mmHg, diastolic blood pressure\>90 mmHg);
• Received major surgical operations or suffered severe traumatic injury, fracture or ulcer within 4 weeks of enrollment;
• Patients with severe myelosuppression at screening;
• Patients with severe liver dysfunction (Child's Class III) or renal dysfunction at screening ;
• Arterial/venous thrombotic events such as cardiovascular and cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction, myocardial infarction), deep vein thrombosis and pulmonary embolism, that occurred within 6 months before randomization;
• 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 (2)

• Cho E, Wu Q, Rubinstein L, Linden H, Gralow J, Specht J, Gadi V, Ellis G. Adjuvant continuous metronomic adriamycin + cyclophosphamide followed by weekly nab-paclitaxel for high-risk early-stage breast cancer. Breast J. 2018 Jul;24(4):610-614. doi: 10.1111/tbj.13013. Epub 2018 Mar 13.

  PMID: 29532546 BACKGROUND

• Robert N, Krekow L, Stokoe C, Clawson A, Iglesias J, O'Shaughnessy J. Adjuvant dose-dense doxorubicin plus cyclophosphamide followed by dose-dense nab-paclitaxel is safe in women with early-stage breast cancer: a pilot study. Breast Cancer Res Treat. 2011 Jan;125(1):115-20. doi: 10.1007/s10549-010-1187-2. Epub 2010 Oct 14.

  PMID: 20945091 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 10, 2022
• First Posted: June 15, 2022
• Study Start: July 10, 2022
• Primary Completion (Estimated): July 10, 2027
• Study Completion (Estimated): December 20, 2027
• Last Updated: July 1, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)