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Breast CancerPhase 2NCT00723125

Carboplatin, Abraxane, Avastin as Neoadjuvant Therapy for Her2-Negative Breast Cancer

A Phase 2 study testing Abraxane, Carboplatin and Avastin in people with Breast Cancer, run by William Sikov MD at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In the MDACC/BrUOG neoadjuvant trial with weekly paclitaxel followed by Fluorouracil Plus Doxorubicin and Cyclophosphamide (FAC), the pathologic complete response (pCR) rate in HER2(-) patients was 20%. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Abraxane, Carboplatin and Avastin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
5 sitesUnited States
Study dates
Sep 2008to 15 May 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically documented adenocarcinoma of the breast
  • ANC > 1000 cells
  • Female; age > 18
  • Zubrod PS 0-1
  • Platelets > 100,000
  • Stage IIA-IIIB disease
Show all 19Show fewer
  • Total bilirubin < 1.5 ULN
  • No evidence of any metastatic disease
  • Serum Creatinine < 1.5 gm/dl
  • No prior systemic therapy for breast cancer or Creat Cl > 30 ml/min
  • Not pregnant or lactating
  • Serum ALT < 2.0 ULN
  • ER, PR and HER2 status required
  • LVEF (MUGA/echo WNL)
  • No baseline > 2 neuropathy
  • Urine protein: creat ratio < 1.0
  • HER2-negative - either IHC 0-1+ or FISH ratio < 2.0
  • Hemoglobin > 9 gm/dl
  • (FISH testing is required for all HER2 2-3+ tumors by IHC)

Who cannot join

  • No Histologically documented adenocarcinoma of the breast
  • No-ANC > 1000 cells
  • Female; age < 18
  • Zubrod PS > 0-1
  • Platelets < 100,000
  • Stage IV disease
Show all 15Show fewer
  • Total bilirubin > 1.5 ULN
  • metastatic disease
  • Serum Creatinine > 1.5 gm/dl
  • prior systemic therapy for breast cancer or Creat Cl > 30 ml/min
  • pregnant or lactating
  • Serum ALT > 2.0 ULN baseline > 2 neuropathy
  • Urine protein: creat ratio >1.0
  • HER2-positive
  • Hemoglobin < 9 gm/dl

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Bridgeport Hospital

    Bridgeport, Connecticut, 06610

  • Yale Smilow Cancer Center

    New Haven, Connecticut, 06519

  • Rhode Island Hsopital

    Providence, Rhode Island, 02903

  • Women and Infants

    Providence, Rhode Island, 02905

  • The Miriam Hospital

    Providence, Rhode Island, 02906

Other trials in United States

About this study

Official title: Q3week Carboplatin With Weekly Abraxaneä And Avastin + Subsequent Dose-Dense Ac With Avastin As Neoadjuvant Therapy In Resectable And Unresectable (Stage Iia-Iiib) Her2-Negative Breast Cancer

In the MDACC/BrUOG neoadjuvant trial with weekly paclitaxel followed by Fluorouracil Plus Doxorubicin and Cyclophosphamide (FAC), the pathologic complete response (pCR) rate in HER2(-) patients was 20%. The investigators' goal is to develop an induction chemotherapy regimen that will have a pCR rate above 30% in patients with HER2(-) disease. Based on a 1-sided 95% confidence interval using normal approximation with an expected pCR rate of at least 35%, approximately 28 patients are required for each cohort. With an assumed pCR rate of at least 35%, the investigators will have approximately 70% statistical power to conclude, with 90% certainty, that the pCR rate with the novel regimen exceeds 20%. The study will accrue approximately 60 patients in two cohorts with an inevaluable rate that does not exceed 10%.

Read the detailed description

See above brief summary

Conditions
Breast Cancer
Being tested
Abraxane, Carboplatin, Avastin
Keywords
Breast Cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbraxaneDrug

    Also called Paclitaxel Protein-Bound

    Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks

  • CarboplatinDrug

    Also called Paraplatin

    Carboplatin at AUC 6 over 30 min IV weeks 1,4,7, and 10

  • AvastinDrug

    Also called Bevacizumab

    Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)

Study groups in NCT00723125
Study groupRoleWhat they receive
Cohort 1ExperimentalAvastin 10 mg/kg IV over 90 minutes day -14 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks
Receives: Drug: Abraxane; Drug: Carboplatin; Drug: Avastin
Cohort 2ExperimentalAbraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7 Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles followed by Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks
Receives: Drug: Abraxane; Drug: Carboplatin; Drug: Avastin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological Complete Response Rates at Surgery

    Measured: at surgery approximately 5 months after initial treatment

Secondary outcomes (1)

  1. Number of Participants With Adverse Events

    Measure of safety and tolerability according to CTCAE version 3.0

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2008 (estimated)
  2. Study startSep 2008
  3. Primary completion15 May 2014
  4. Study completion15 May 2014

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00723125
Sponsor's protocol ID
BrUOG-BR-211A
Status last verified
Apr 2021
First submitted
15 Jul 2008
Last updated
29 Apr 2021
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abraxane, Carboplatin and Avastin in people with Breast Cancer, run by William Sikov MD at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological Complete Response Rates at Surgery (time frame: at surgery approximately 5 months after initial treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00723125.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.

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