Stage I Breast Cancer AJCC v7Phase 2NCT02593175
Women's MoonShot: Neoadjuvant Treatment With PaCT for Patients With Locally Advanced TNBC
A Phase 2 study testing Carboplatin, Paclitaxel and Panitumumab in people with Stage I Breast Cancer AJCC v7 and Stage IA Breast Cancer AJCC v7, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7
- What is being tested?
- Carboplatin, Paclitaxel and Panitumumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2016to 3 Apr 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
- Male patients whose sexual partner(s) are WOCBP who are not willing to use adequate contraception, during the study and for 8 weeks after the end of treatment
- Negative serum or urine pregnancy test for women within 72 hours of receiving the first dose of the study medication for women of childbearing potential
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Women's Triple-Negative First-Line Study: A Phase II Trial of Panitumumab, Carboplatin and Paclitaxel (PaCT) in Patients With Localized Triple-Negative Breast Cancer (TNBC) With Tumors Predicted Insensitive to Standard Neoadjuvant Chemotherapy
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the pathologic complete response (pCR), residual cancer burden (RCB)-0 and RCB-I rates of patients with localized TNBC who were treated with panitumumab, carboplatin and paclitaxel (PaCT) in the neoadjuvant setting.
SECONDARY OBJECTIVES:
- To estimate progression free survival (PFS) distribution of localized TNBC patients who were non-responders to initial anthracycline and cyclophosphamide chemotherapy, and who were treated with the PaCT regimen in the neoadjuvant setting.
II. Determine changes of epidermal growth factor receptor (EGFR) downstream biomarkers one week after 1 dose of panitumumab.
III. Determine response rate after 4 cycles of PaCT using radiographic imaging. IV. Correlate pathologic response with EGFR expression as measured by immunohistochemistry (IHC).
- Determine toxicity associated to 4 cycles of PaCT in the neoadjuvant setting.
VI. Compare pathologic response to 4 cycles of PaCT in EGFR overexpressing tumors versus (vs.) non-EGFR overexpressing tumors.
VII. Compare pathologic response in tumors to 4 cycles of PaCT vs. 12 weeks of weekly paclitaxel (using data collected in conjunction with protocol 2014-0185).
EXPLORATORY OBJECTIVES:
- Determine the correlation between EGFR expression by IHC and the presence of enhanced EGFR gene signatures at the time of initial tumor biopsy prior to neoadjuvant setting (NACT) (using gene expression data obtained from the protocol 2014-0185).
II. Determine rates of pCR in patients with EGFR overexpressed tumors identified by gene signatures (using gene expression data obtained from protocol 2014-0185) and compare to pCR rates in non-EGFR overexpressed tumors.
III. Determine the correlation between EGFR expression by IHC and the changes of EGFR downstream changes induced in surgery sample after completion of PaCT regimen.
IV. Determine the change in programmed cell death ligand 1 (PD-L1) glycosylation induced by panitumumab, and correlation with efficacy.
- Determine the change after treatment in blood-based markers, if any, and use these to predict a response to panitumumab treatment.
OUTLINE:
Patients receive panitumumab intravenously (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.
After completion of study treatment, patients are followed up every 3-4 months.
- 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
- Being tested
- Carboplatin, Paclitaxel, Panitumumab
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino
Given IV
PaclitaxelDrug
Also called Anzatax, Asotax, Bristaxol, Praxel
Given IV
PanitumumabBiological
Also called ABX-EGF, ABX-EGF Monoclonal Antibody, ABX-EGF, Clone E7.6.3, MoAb ABX-EGF
Given IV
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Carboplatin; Drug: Paclitaxel; Biological: Panitumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study start3 Nov 2016
- Primary completion3 Apr 2025
- Study completion3 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stage I Breast Cancer AJCC v7Studies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clinton Yam, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593175
- Sponsor's protocol ID
- 2015-0294
- Other IDs
- NCI-2015-02183, 2015-0294
- Status last verified
- Oct 2025
- First submitted
- 29 Oct 2015
- Last updated
- 6 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 39356138