NCT01953588|Active Not RecruitingPhase 3DMC

Fulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III Breast Cancer Undergoing Surgery

Alternate Approaches for Clinical Stage II or III Estrogen Receptor Positive Breast Cancer Neoadjuvant Treatment (ALTERNATE) in Postmenopausal Women: A Phase III Study

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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3 other identifiers

A011106NCI-2013-01340U10CA031946

Study Type

interventional

Target

1,473

Locations

2 countries

Sites

860

Timeline

RegisteredOct 2013

StartedFeb 2014

CompletionApr 2027

Brief Summary

The study is being conducted to determine whether neoadjuvant endocrine therapy with fulvestrant or the combination of anastrozole and fulvestrant, is better than anastrozole when given before surgery to shrink the cancer and stop it from growing. Anastrozole inhibits tumor growth by reducing the levels of estrogen and has been approved by the Food and Drug Administration (FDA) of the United States for use after surgery for postmenopausal women with estrogen receptor positive breast cancer. It is also considered a standard of care to give anastrozole for a few months before surgery to shrink the tumor. Fulvestrant inhibits tumor cell growth by reducing the levels of estrogen receptor in the tumor cell. It is not approved by the FDA for use in women with early stage breast cancer before or after surgery, but is approved by the FDA for patients with advanced (Stage 4) estrogen receptor positive breast cancer that has spread to other parts of the body.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,473

participants targeted

Target at P75+ for phase_3

Timeline

11mo left

Started Feb 2014

Longer than P75 for phase_3

Geographic Reach

2 countries

860 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

13.1 years study duration

Study Progress93%

Feb 2014Apr 2027

First Submitted

Initial submission to the registry

September 25, 2013

Completed

6 days until next milestone

First Posted

Study publicly available on registry

October 1, 2013

Completed

5 months until next milestone

Study Start

First participant enrolled

February 27, 2014

Completed

13.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

13.1 years

First QC Date

September 25, 2013

Last Update Submit

January 20, 2026

Conditions

Recurrent Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Estrogen Receptor-positive Breast Cancer HER2-negative Breast Cancer Invasive Ductal Breast Carcinoma Invasive Lobular Breast Carcinoma

Outcome Measures

Primary Outcomes (3)

Rate of endocrine resistant disease-(First Phase)
Up to 24 weeks
Pathologic complete response rate-(pCR rate)
Up to 24 weeks
Recurrence-free survival (RFS)-(Second Phase)
Up to 5 years

Study Arms (3)

Arm I (anastrozole)

ACTIVE COMPARATOR

Patients receive anastrozole daily for 6 cycles followed by surgery. A treatment cycle is 4 weeks in length. After completion of analysis of endocrine resistant data, patients will continue treatment as defined in the protocol.

Drug: anastrozole

Arm II (fulvestrant)

ACTIVE COMPARATOR

Patients receive fulvestrant on days 1 and 15 of cycle 1 and day 1 of cycles 2-6 followed by surgery. A treatment cycle is 4 weeks in length. After completion of analysis of endocrine resistant data, patients will continue treatment as defined in the protocol.

Drug: fulvestrant

Arm III (anastrozole and fulvestrant)

ACTIVE COMPARATOR

Patients receive anastrozole daily in combination with fulvestrant on days 1 and 15 of cycle 1, and on day 1 of cycles 2-6 followed by surgery. A treatment cycle is 4 weeks in length. After completion of analysis of endocrine resistant data, patients will continue treatment as defined in the protocol.

Drug: fulvestrantDrug: anastrozole

Interventions

fulvestrantDRUG

Fulvestrant 500 mg IM

Also known as: Faslodex®

Arm II (fulvestrant)Arm III (anastrozole and fulvestrant)

anastrozoleDRUG

Anastrozole 1 mg oral tablet

Also known as: Arimidex®

Arm I (anastrozole)Arm III (anastrozole and fulvestrant)

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Female ≥18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Postmenopausal, verified by:
post bilateral surgical oophorectomy or
no spontaneous menses ≥ 1 year or
no menses for \< 1 year with follicle-stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards
Pathologic confirmation of invasive breast cancer diagnosed by core needle biopsy
Clinical T2-T4c, any N, M0 invasive breast cancer, by AJCC 7th edition clinical staging, with the goal being surgery to complete excision of the tumor in the breast and the lymph node. Primary tumor must be:
palpable
its largest diameters is at least 2.0 cm by physical examination or by radiological assessment
Note:
Patients with contralateral ductal carcinoma in situ and/or invasive breast cancer are not eligible.
Patients with multi-centric breast cancer (defined as more than one lesion is invasive breast cancer in the same breast separated by ≥ 2 cm of normal breast tissue are not eligible.
Invasive breast cancer is estrogen receptor positive with an Allred score of 6, 7 or 8 by local institution standard protocol. If an Allred Score is not reported on the diagnostic pathology report, ER positivity in \> 66% cells is eligible. If ER positivity is ≤ 66%, the staining intensity (weak, intermediate, strong) is needed to calculate the Allred Score to determine eligibility.
Invasive breast cancer is Human Epidermal Growth Factor Receptor 2 (HER2)- A patient is considered to have HER2 negative breast cancer if one of the following applies:
+11 more criteria

You may not qualify if:

Premenopausal status
Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d' orange without erythema).
An excisional biopsy of this breast cancer.
Hormone replacement therapy of any type, megestrol acetate, or raloxifene within one week prior to registration.
Tumor estrogen receptor (ER) Allred score between 0-5 or HER2 positive by IHC (3+) or amplified by FISH \> 2.0.
Surgical axillary staging procedure prior to study entry. Note: Fine needle aspiration (FNA) or core needle biopsy of axillary node is permitted.
Clinical or radiographic evidence of metastatic disease. Metastatic workup is not required, but is recommended for patients with clinical stage III disease. Note: Isolated ipsilateral supraclavicular node involvement is permitted.
Breast implants are contraindicated only if the implant precludes the required research biopsies or interferes with palpating the breast lesion.
Treatment for this cancer including surgery, radiation therapy, chemotherapy, biotherapy, hormonal therapy or investigational agent prior to study entry.
History of invasive breast cancer or contralateral DCIS.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Alliance for Clinical Trials in Oncologylead
National Cancer Institute (NCI)collaborator

Study Sites (860)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

Location

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, 36688, United States

Location

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

Location

Anchorage Radiation Therapy Center

Anchorage, Alaska, 99504, United States

Location

Alaska Breast Care and Surgery LLC