Women's MoonShot: Neoadjuvant Treatment With PaCT for Patients With Locally Advanced TNBC

NCT02593175 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 2015-0294NCI-2015-02183
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well panitumumab, carboplatin and paclitaxel work in treating patients with newly diagnosed triple negative breast cancer that is limited to the breast and possibly to the nearby lymph nodes (locally advanced). This treatment study is linked to NCI-2015-00191 protocol, which uses a baseline biopsy to determine the neoadjuvant therapy that matches the sub-type of triple negative breast cancer (TNBC). Immunotherapy with panitumumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving panitumumab, carboplatin and paclitaxel before surgery may be an effective treatment for breast cancer by making the tumor smaller and reducing the amount of normal tissue that needs to be removed.

Conditions

Stage I Breast Cancer AJCC v7; Stage IA Breast Cancer AJCC v7; Stage IB Breast Cancer AJCC v7; Stage II Breast Cancer AJCC v6 and v7; Stage IIA Breast Cancer AJCC v6 and v7; Stage IIB Breast Cancer AJCC v6 and v7; Stage III Breast Cancer AJCC v7; Stage IIIA Breast Cancer AJCC v7; Stage IIIB Breast Cancer AJCC v7; Stage IIIC Breast Cancer AJCC v7; Triple-Negative Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Residual Disease

  Residual Disease at the time of surgery, which can help predict disease recurrence and survival across all breast cancer subtypes.

  At the time of surgery

Study Arms (1)

Treatment (panitumumab, paclitaxel, carboplatin)

EXPERIMENTAL

Patients receive panitumumab IV over 30 minutes and paclitaxel IV over 30 minutes on days 1, 8, and 15. Patients also receive carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

Drug: Carboplatin; Drug: Paclitaxel; Biological: Panitumumab

Interventions

Carboplatin DRUG

Given IV

Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo

Treatment (panitumumab, paclitaxel, carboplatin)

Paclitaxel DRUG

Given IV

Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

Treatment (panitumumab, paclitaxel, carboplatin)

Panitumumab BIOLOGICAL

Given IV

Also known as: ABX-EGF, ABX-EGF Monoclonal Antibody, ABX-EGF, Clone E7.6.3, MoAb ABX-EGF, Monoclonal Antibody ABX-EGF, Vectibix

Treatment (panitumumab, paclitaxel, carboplatin)

Eligibility Criteria

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

You may qualify if:

• Patients must have an intact evaluable primary tumor or biopsy proven axillary node involvement with at least 1.0 centimeter (cm) smallest dimension based on imaging after neoadjuvant anthracycline-based chemotherapy and prior to initiation of neoadjuvant chemotherapy under this protocol; baseline measurements and evaluations must be obtained within 4 weeks of registration to the study; all areas of disease should be recorded in order to assess response and uniformity of response to therapy
• Triple-negative breast cancer defined as estrogen receptor (ER) \< 10%; progesterone receptor (PR) \< 10% by immunohistochemistry (IHC) and human epidermal growth factor receptor 2 (HER2) 0-1 positive (+) by IHC or 2+, fluorescence in situ hybridization (FISH) \< 2, gene copy number \< 4
• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Patients must have received at least one dose of an anthracycline based neoadjuvant regimen; patients are eligible if therapy was discontinued due to disease progression or therapy intolerance
• Baseline multi-gated acquisition (MUGA) or echocardiogram showing left ventricular ejection fraction (LVEF) \>= 50% within 6 weeks prior to initiation of neoadjuvant chemotherapy
• Serum creatinine =\< 1.5 mg/dl
• Creatinine clearance (CrCl) \>= 50 mL/min calculated by the Cockcroft-Gault method
• Absolute neutrophil count (ANC) \>= 1500/mm\^3
• Platelets \>= 100,000/mm\^3
• Hemoglobin \>= 9.0 g/dL
• Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) \< 3.0 x upper limit of normal
• Alkaline phosphatase (Alp) =\< 2.5 x upper limit of normal (ULN)
• Total bilirubin =\< 1.5 x ULN
• Signed informed consent

You may not qualify if:

• Patient is unwilling or unable to sign and date the Institutional Review Board (IRB) approved informed consent
• Patients with less than a 1.0 cm measurable residual disease after neoadjuvant anthracycline based chemotherapy
• Women that are pregnant or lactating
• Patients with a history of prior malignancy within 5 years of study entry with the exception of curatively treated non-melanomatous skin cancer or carcinoma in situ of the cervix or breast
• Patients with a history of stage IV or metastatic disease
• Any serious medical illness, other than that treated by this study, which would limit survival to less than 1 month or psychiatric illness which would limit informed consent
• Known positive test(s) for human immunodeficiency virus infection, hepatitis C virus, acute or chronic active hepatitis B infection
• Patients with a peripheral neuropathy \> grade 1
• Patients with a history of serious cardiac events defined as: New York Heart Association class 3 or 4 heart failure, or history of myocardial infarction, unstable angina or cerebrovascular accident (CVA) within 6 months of protocol registration
• Patients with a history of PR prolongation or atrioventricular (AV) block
• Patients with a history of prior therapy with paclitaxel and/or carboplatin
• Patients who have received a cumulative dose of doxorubicin of greater than 360 mg/m\^2 or epirubicin of greater than 640 mg/m\^2
• Patients who concurrently use hormonal therapy and/or concurrent radiation therapy
• Patients who had prior radiation therapy of the primary breast carcinoma or axillary lymph nodes
• Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must use highly effective methods of contraception during the study and 8 weeks after; highly effective contraception methods include combination of any two of the following: placement of an intrauterine device (IUD) or intrauterine system (IUS), barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository, total abstinence or male/female sterilization; women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to treatment; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child-bearing potential

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Yam C, Patel M, Hill HA, Sun R, Bassett RL Jr, Kong E, Damodaran S, Koenig KB, Abouharb S, Saleem S, Bisen AK, Murthy RK, Ramirez DL, Rauch GM, Adrada BE, Candelaria RP, Wang X, Mittendorf EA, Thompson AM, White JB, Ravenberg EE, Clayborn AR, Ding QQ, Booser DJ, Oke O, Brewster AM, Hortobagyi GN, Ibrahim NK, Litton JK, Valero V, Arun BK, Tripathy D, Chang JT, Chen K, Korkut A, Moulder SL, Huo L, Lim B, Ueno NT. Targeting the Epidermal Growth Factor Receptor Pathway in Chemotherapy-Resistant Triple-Negative Breast Cancer: A Phase II Study. Cancer Res Commun. 2024 Oct 1;4(10):2823-2834. doi: 10.1158/2767-9764.CRC-24-0255.

  PMID: 39356138 DERIVED

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

Carboplatin; Paclitaxel; Taxes; Panitumumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Clinton Yam
• Organization: MD Anderson Cancer Center

cyam@mdanderson.org

832-589-8343

Study Officials

• Clinton Yam

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: October 29, 2015
• First Posted: October 30, 2015
• Study Start: November 3, 2016
• Primary Completion: April 3, 2025
• Study Completion: April 3, 2025
• Last Updated: November 6, 2025
• Results First Posted: November 6, 2025

Record last verified: 2025-10

Locations

US (1)