ADCb (Anlotinib/Docetaxel/Carboplatin) as Neoadjuvant Therapy for Triple-Negative Breast Cancer

NCT04975451 | Unknown Phase 2

• 1 other identifier: GDWCH002(TNBC)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

DCb (docetaxel/carboplatin) regimens as Neoadjuvant Treatment for Triple-Negative Breast Cancer have been recommended by NCCN guideline.Combination of anti-angiogenesis inhibitors is expected to further improvePathologic Complete Response(PCR).This study is to evaluate the efficacy and safety of ADCb (Anlotinib/docetaxel/carboplatin) as Neoadjuvant Treatment in Triple-Negative breast cancer. The endpoint of PCR is used as a surrogate marker for survival. Safety and tolerability assessed by number of grade 4 toxicities and hospitalizations.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response(PCR)

  Local evaluation of pCR defined as the absence of any residual invasive cancer of the resected breast specimen and all sampled ipsilateral lymph nodes (i.e., ypT0/is, ypN0 in the current AJCC staging system

  Up to approximately 20-25 weeks

Secondary Outcomes (2)

• event-free survival(EFS)

  Up to approximately 24 months

• Safety and Tolerability

  Up to approximately 20-25 weeks

Study Arms (1)

ADCb

EXPERIMENTAL

Anlotinib (anlotinib 12mg qd p.o. d1-14/21day/cycle)and Docetaxel (75 mg/m2 administered intravenously every 3 weeks) and carboplatin (area under the concentration-time curve \[AUC\] 6, intravenously every 3 weeks) for six cycles

Drug: Anlotinib

Interventions

Anlotinib DRUG

Anlotinib plus DCb

ADCb

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female, aged 18 Years to 75 Years
• Signed written informed consent approved by the study site Ethics Committee
• Histologically confirmed Triple-Negative invasive breast carcinoma：Pathologically confirmed as triple negative, defined as ER and PR expression both \< 1 % of tumor cell nuclei per ASCO/CAP guidelinesa and HER2 negative per ASCO/CAP guidelinesa (IHC 0 or 1+ or FISH-, or IHC 2+ and FISH-)
• Stage at presentation: II - III (T1cN1-2 or T2-4N0-2)
• Patients must have measurable disease as defined by palpable lesion with caliper and/or a positive mammogram or ultrasound. Bilateral mammogram is required for study entry. Baseline measurements of the indicator lesions must be recorded on the Patient Registration Form. To be valid for baseline, the measurements must have been made within the 14 days if palpable. If not palpable, a mammogram or MRI must be done within 14 days. If palpable, a mammogram or MRI must be done within 2 months prior to study entry. If clinically indicated, x-rays and scans must be done within 28 days of study entry.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 within 14 days of study entry
• Adequate organ function within 2 weeks of study entry:
• ANC ≥ 1500 cells/μL Platelet count ≥ 100,000 cells/μL Hemoglobin ≥ 9 g/dL; patients may receive red blood cell transfusions to obtain this level Serum creatinine ≤ 1.5 × upper limit of normal (ULN) INR and (activated) partial thromboplastin time (aPTT/PTT) ≤ 1.5 ×ULN AST and ALT ≤ULN Serum total bilirubin ≤ ULN, except for patients with Gilbert's syndrome for whom direct bilirubin should be within the normal range Serum alkaline phosphatase ≤ULN
• Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
• Women of childbearing potential must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation

You may not qualify if:

• Stage IV (metastatic) breast cancer
• Patients with a history of invasive breast cancer.
• Patients with a history of ductal carcinoma in situ (DCIS), except for patients treated exclusively with mastectomy \> 5 years prior to diagnosis of current breast cancer
• Patients with bilateral breast cancer
• Prior chemotherapy, hormonal therapy, biologic therapy, investigational agent, targeted therapy or radiation therapy for current breast cancer.
• Patients who have undergone incisional and/or excisional biopsy of primary tumor and/or axillary lymph nodes
• History of previous or current malignancy at other sites with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies, who remain disease free for greater than five years are eligible.
• Current severe, uncontrolled systemic disease that may interfere with planned treatment (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease; wound-healing disorders)
• Major surgical procedure unrelated to breast cancer or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment
• Current pregnancy and/or breastfeeding

Sponsors & Collaborators

• Anqin Zhang: lead

Study Sites (1)

Guangdong Women and Children Hospital

Guangzhou, Guangdong, 511400, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

anlotinib

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Anqin Zhang, master

CONTACT

020-39151720; 30542933@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: July 23, 2021
• Study Start: October 1, 2021
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: July 27, 2021

Record last verified: 2021-07

Locations

CN (1)